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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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GSK Duchenne drug gets ‘breakthrough’ status


The US Food and Drug Administration has granted breakthrough therapy designation to GlaxoSmithKline’s drisapersen for the potential treatment of patients with Duchenne muscular dystrophy. read all at

http://www.pharmatimes.com/Article/13-06-28/GSK_Duchenne_drug_gets_breakthrough_status.aspx

Drisapersen (also known as PRO051 and GSK2402968 ) is an experimental drug under development by Prosensa for the treatment of Duchenne muscular dystrophy.

The compound is in a Phase III trial which is anticipated to complete by the end of 2013.

Drisapersen CAS# 1251830-50-8, has been touted by GlaxoSmithKline and Sarepta as a potential treatment to aid patients with DMD. Results from an early-stage study of drisapersen have been hopeful. Drisapersen is effectual in that it specifically induces exon 51 skipping in the DMD gene. A small, but telling trial of four patients with Duchenne muscular dystrophy offered clinical proof of the effectiveness of drisapersen. In this controlled trial four patients with DMD were administered a single intramuscular 0.8 mg dose of drisapersen. This one dose proved to not only be tolerable and safe, but it also proved to successfully induce exon 51 skipping and dystrophin restoration, up to 35% of normal. The dystrophin restoration was also restored in the majority, up to 94%, of the muscle fibers after the injection. Trials are continuing for the use of drisapersen in treating Duchenne muscular dystrophy in the United States. – See more at: http://www.lgmpharma.com/blog/hope-is-on-the-horizon-for-patients-with-duchenne-muscular-dystrophy/#sthash.oeXyYKc0.dpuf
Drisapersen CAS# 1251830-50-8, has been touted by GlaxoSmithKline and Sarepta as a potential treatment to aid patients with DMD. Results from an early-stage study of drisapersen have been hopeful. Drisapersen is effectual in that it specifically induces exon 51 skipping in the DMD gene. A small, but telling trial of four patients with Duchenne muscular dystrophy offered clinical proof of the effectiveness of drisapersen. In this controlled trial four patients with DMD were administered a single intramuscular 0.8 mg dose of drisapersen. This one dose proved to not only be tolerable and safe, but it also proved to successfully induce exon 51 skipping and dystrophin restoration, up to 35% of normal. The dystrophin restoration was also restored in the majority, up to 94%, of the muscle fibers after the injection. Trials are continuing for the use of drisapersen in treating Duchenne muscular dystrophy in the United States. – See more at: http://www.lgmpharma.com/blog/hope-is-on-the-horizon-for-patients-with-duchenne-muscular-dystrophy/#sthash.oeXyYKc0.dpuf
  1. ^ “PRO051/GSK2402968”. Prosensa. Retrieved 29 October 2012
  2. ^ “A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD114044)”. ClinicalTrials.gov. Retrieved 29 October 2012.

 

Drisapersen CAS# 1251830-50-8, has been touted by GlaxoSmithKline and Sarepta as a potential treatment to aid patients with DMD. Results from an early-stage study of drisapersen have been hopeful. Drisapersen is effectual in that it specifically induces exon 51 skipping in the DMD gene. A small, but telling trial of four patients with Duchenne muscular dystrophy offered clinical proof of the effectiveness of drisapersen. In this controlled trial four patients with DMD were administered a single intramuscular 0.8 mg dose of drisapersen. This one dose proved to not only be tolerable and safe, but it also proved to successfully induce exon 51 skipping and dystrophin restoration, up to 35% of normal. The dystrophin restoration was also restored in the majority, up to 94%, of the muscle fibers after the injection. Trials are continuing for the use of drisapersen in treating Duchenne muscular dystrophy in the United States. – See more at: http://www.lgmpharma.com/blog/hope-is-on-the-horizon-for-patients-with-duchenne-muscular-dystrophy/#sthash.oeXyYKc0.dpuf
Drisapersen CAS# 1251830-50-8, has been touted by GlaxoSmithKline and Sarepta as a potential treatment to aid patients with DMD. Results from an early-stage study of drisapersen have been hopeful. Drisapersen is effectual in that it specifically induces exon 51 skipping in the DMD gene. A small, but telling trial of four patients with Duchenne muscular dystrophy offered clinical proof of the effectiveness of drisapersen. In this controlled trial four patients with DMD were administered a single intramuscular 0.8 mg dose of drisapersen. This one dose proved to not only be tolerable and safe, but it also proved to successfully induce exon 51 skipping and dystrophin restoration, up to 35% of normal. The dystrophin restoration was also restored in the majority, up to 94%, of the muscle fibers after the injection. Trials are continuing for the use of drisapersen in treating Duchenne muscular dystrophy in the United States. – See more at: http://www.lgmpharma.com/blog/hope-is-on-the-horizon-for-patients-with-duchenne-muscular-dystrophy/#sthash.oeXyYKc0.dpuf
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Lyxumia approved in Japan for the treatment of type 2 diabetes


lyxumia, LIXISENATIDE

READ ALL AT

http://www.pharmaintellect.com/2013/06/lyxumia-approved-in-japan-for-treatment.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

OLD ARTICLE

https://newdrugapprovals.wordpress.com/2013/02/05/eu-approves-lyxumia-lixisenatide-sanofi-for-the-treatment-of-type-2-diabetes/

 

 

GALL BLADDER STONES, FACTS



Numerous small gallstones made up largely of cholesterol.

A gallstone is a crystalline concretion formed within the gallbladder by accretion of bile components. These calculi are formed in the gallbladder but may distally pass into other parts of the biliary tract such as the cystic duct, common bile duct, pancreatic duct, or the ampulla of Vater. Rarely, in cases of severe inflammation, gallstones may erode through the gallbladder into adherent bowel potentially causing an obstruction termed gallstone ileus.

Presence of gallstones in the gallbladder may lead to acute cholecystitis,[2] an inflammatory condition characterized by retention of bile in the gallbladder and often secondary infection by intestinal microorganisms, predominantly Escherichia coli, Klebsiella, Enterobacter, and Bacteroides species.Presence of gallstones in other parts of the biliary tract can cause obstruction of the bile ducts, which can lead to serious conditions such as ascending cholangitis or pancreatitis. Either of these two conditions can be life-threatening and are therefore considered to be medical emergencies

Symptoms

Gallstones may be asymptomatic, even for years. These gallstones are called “silent stones” and do not require treatment.Symptoms commonly begin to appear once the stones reach a certain size (>8 mm). A characteristic symptom of gallstones is a “gallstone attack”, in which a person may experience intense pain in the upper-right side of the abdomen, often accompanied by nausea and vomiting, that steadily increases for approximately 30 minutes to several hours. A patient may also experience referred pain between the shoulder blades or below the right shoulder. These symptoms may resemble those of a “kidney stone attack”. Often, attacks occur after a particularly fatty meal and almost always happen at night, and after drink.

A positive Murphy’s sign is a common finding on physical examination.

Causes

Gallstone risk increases for females (especially before menopause) and for people near or above 40 years; the condition is more prevalent among both North and South Amerindians and among those of European descent than among other ethnicities. A lack of melatonin could significantly contribute to gallbladder stones, as melatonin inhibits cholesterol secretion from the gallbladder, enhances the conversion of cholesterol to bile, and is an antioxidant, which is able to reduce oxidative stress to the gallbladder.Researchers believe that gallstones may be caused by a combination of factors, including inherited body chemistry, body weight, gallbladder motility (movement), and perhaps diet. The absence of such risk factors does not, however, preclude the formation of gallstones.

No clear relationship has been proved between diet and gallstone formation; however, low-fiber and high-cholesterol diets have been suggested as contributing to gallstone formation. Other nutritional factors that may increase risk of gallstones include rapid weight loss; constipation; eating fewer meals per day; and low intake of the nutrients folate, magnesium, calcium, and vitamin C. On the other hand, wine and whole-grained bread may decrease the risk of gallstones. Pigment gallstones are most commonly seen in the developing world. Risk factors for pigment stones include hemolytic anemias (such as sickle-cell disease and hereditary spherocytosis), cirrhosis, and biliary tract infections. People with erythropoietic protoporphyria (EPP) are at increased risk to develop gallstones. Additionally, prolonged use of proton pump inhibitors has been shown to decrease gallbladder function, potentially leading to gallstone formation

Diet is the fundamental part in the treatment of gall bladder disorders. In cases of acute gall-bladder inflammation, the patient should fast for two or three days, until the acute condition clears. Nothing but water should be taken during the fast. After the fast, the patient should take carrot, beet, grape fruit, lemon and grape juice for a few days. The diet should contain a sufficient amount of lacto-vegetarian, consisting of raw and cooked vegetables, vegetable juices, and a moderate amount of fruit and seeds. Yogurt, cottage cheese and a tablespoon of olive oil twice a day should also be taken.

All meats, eggs, animal fats and processed and denatured fats as well as fried foods should be avoided. The diet should also keep out refined carbohydrates, particularly sugar, sugar products, alcohol, soft drinks, cakes, puddings, ice-cream, coffee and citrus fruits. The patient should eat small meals at regular intervals, rather than three large meals.

Treatment

Medical

Cholesterol gallstones can sometimes be dissolved by oral ursodeoxycholic acid, but it may be necessary for the patient to take this medication for up to two years. Gallstones may recur, however, once the drug is stopped. Obstruction of the common bile duct with gallstones can sometimes be relieved by endoscopic retrograde sphincterotomy (ERS) following endoscopic retrograde cholangiopancreatography (ERCP). Gallstones can be broken up using a procedure called extracorporeal shock wave lithotripsy (often simply called “lithotripsy”), which is a method of concentrating ultrasonic shock waves onto the stones to break them into tiny pieces. They are then passed safely in the feces. However, this form of treatment is suitable only when there is a small number of gallstones.

Surgical

Cholecystectomy (gallbladder removal) has a 99% chance of eliminating the recurrence of cholelithiasis. Surgery is only indicated in symptomatic patients. The lack of a gallbladder may have no negative consequences in many people. However, there is a portion of the population — between 10 and 15% — who develop a condition called postcholecystectomy syndrome which may cause gastrointestinal distress and persistent pain in the upper-right abdomen, as well as a 10% risk of developing chronic diarrhea.

There are two surgical options for cholecystectomy:

  • Open cholecystectomy is performed via an abdomenal incision (laparotomy) below the lower right ribs. Recovery typically requires 3–5 days of hospitalization, with a return to normal diet a week after release and to normal activity several weeks after release.
  • Laparoscopic cholecystectomy, introduced in the 1980s, is performed via three to four small puncture holes for a camera and instruments. Post-operative care typically includes a same-day release or a one night hospital stay, followed by a few days of home rest and pain medication.[7] Laparoscopic cholecystectomy patients can, in general, resume normal diet and light activity a week after release, with some decreased energy level and minor residual pain continuing for a month or two. Studies have shown that this procedure is as effective as the more invasive open cholecystectomy, provided the stones are accurately located by cholangiogram prior to the procedure so that they can all be removed.
A New Alternative Surgical Technique 

A new surgical technique is available to remove Gallstones without excision of gallbladder. This technique is available in China.

Alternative medicine

A regimen called a “gallbladder flush” or “liver flush” is a popular remedy in alternative medicine.In this treatment, often self-administered, the patient drinks four glasses of pure apple juice (not cider) and eats five apples (or applesauce) per day for five days, then fasts briefly, takes magnesium, and then drinks large quantities of lemon juice mixed with olive oil before bed. The next morning, they painlessly pass a number of green and brown pebbles purported to be stones flushed from the biliary system. Apples are a source of pectin, which has been shown to sequester bile and facilitate its elimination in the stool.

A brief communication in The Lancet presents a case report of such a treatment where the patient released many soft stones. According to the letter, “At the university hospital the stones were recognized as fatty stones”. In another case report, a patient with ultrasonography-confirmed gallstones drank olive oil and lemon juice, suffered diarrhea and intense abdominal pain, and released several gallstones. After that treatment, the gallbladder was empty, as confirmed by ultrasonography.

On the other hand, a couple of case reports challenge whether the stones retrieved from the stool after the “gallbladder flush” really come from the gallbladder. A New Zealand hospital analyzed stones from a typical gallbladder flush and found them to be composed of fatty acids similar to those in olive oil, with no detectable cholesterol or bile salts, demonstrating that they are little more than hardened olive oil. Despite the gallbladder flush, the patient still required surgical removal of multiple true gallstones. A similar case report in The Lancet,accompanied by a simple chemical experiment, concludes that the observed stones from a typical gallbladder flush actually are a consequence of the flush: they form in the stomach under the action of digestive enzymes on the mix of olive oil and lemon.

Finally, drinking an infusion of “Chanca Piedra“, or “Break Stones” (Phyllanthus niruri), a plant that is native to the Amazon, has long been used in South American traditional medicine to maintain kidney, liver, and gallbladder health and to treat gallstones and kidney stones and jaundice.

Other patients have anecdotally reported that symptoms can be temporarily reduced by drinking several glasses of water when experiencing gallstone pain. There is no known evidence backing this claim, and this approach will not eliminate the gallstones or improve the patient’s condition in the long term

Treatment involves removing the stone using ERCP. Typically, the gallbladder is then removed, an operation called cholecystectomy, to prevent a future occurrence of common bile duct obstruction or other complications

FOODS TO AVOID

YOGA

Regular applications of hot and cold fomentations to the abdomen improve the circulation of the liver and gall-bladder. They also stimulate concentrations of the gall-bladder, thereby improving the flow of bile. A cold hip bath improves the general abdominal tone. The pain of gall-stone colic can be relieved by the application of hot packs or fomentation to the upper abdominal area. A warm water enema at body temperature will help eliminate faecal accumulations if the patient is constipated. Exercise is necessary as physical inactivity can lead to lazy gall-bladder type indigestion which may eventually result in the formation of stones. Yogic asanas which are beneficial in toning up the liver and gall-bladder are: sarvangasana, paschimottanasana, salabhasana, dhanurasana and bhujangasana.

TIPS

READ THIS

http://www.ladyzona.com/simple-tips-on-gallbladder-stones-treatment/

 

 

 

 

WORLD DRUG TRACKER group, linkedin, blog etc


World Drug Tracker

worlddrugtracker.blogspot.in/

Labels: anthony crasto, catalyst, DRUGS, medicinal chemistry, New Drugs, organic chemistry, ORGANIC SYNTHESIS, PATENTS, process, world drug tracker 

 

WORLD DRUG TRACKER | LinkedIn

in.linkedin.com/groups/WORLDDRUGTRACKER-5055643

 
 To track information on drugs on worldwide basis, all aspects covered, A group by DR ANTHONY MELVIN CRASTO Ph.D.
 

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Navidea starts clinical trial for Alzheimer’s diagnostic drug


Navidea Biopharmaceuticals hopes to bring an early diagnostic drug for Alzheimer’s disease to market.

 

Navidea Biopharmaceuticals hopes to bring an early diagnostic drug for Alzheimer’s disease to market.

AZD4694, NAV4694 STRUCTURE

Navidea starts clinical trial for Alzheimer’s diagnostic drug
Business First of Columbus
The Phase 3 trial for the Alzheimer’s agent, at the moment named NAV4694, will compare how well the drugdisplays the buildup of a damaging protein in the brain of patients believed to have Alzheimer’s compared with what’s found in the autopsy. There 

read all at

http://www.bizjournals.com/columbus/news/2013/06/27/navidea-starts-clinical-trial-for.html

http://jnm.snmjournals.org/content/54/6/880.abstract

Navidea Biopharmaceuticals, a Dublin, Ohio biopharmaceutical company focused on precision diagnostics, earlier this week announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for Alzheimer’s disease (AD).

NAV4694 is designed to aid visual detection and quantification of cerebral beta amyloid in diagnosing Alzheimer’s disease (AD). One hallmark of AD is the accumulation of beta amyloid plaques between nerve cells in the brain.

The study was designed and conducted by Navidea’s partner, AstraZeneca, to assess the safety and of the biomarker during PET scanning in subjects with AD and in healthy volunteers. Efficacy measures included binding parameters and overall image quality.  The 16-patient trial was completed at Karolinska Institutet sites in Stockholm, Sweden.

FDA Approves Rixubis – First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes


Rixubis [Coagulation Factor IX (Recombinant)]

June 27, 2013 — The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis).

read all at

http://www.drugs.com/newdrugs/fda-approves-rixubis-first-recombinant-coagulation-factor-ix-preventing-bleeding-episodes-3830.html

Date rape drug sensor


 
gamma-butyrolactone

The first fluorescent sensor for known date rape drug gamma-butyrolactone (GBL) has been developed in Singapore. It emits orange fluorescence in alcoholic drinks containing GBL when irradiated with a green laser.

Gamma-butyrolactone (GBL) is a readily available industrial solvent that is often used as a date rape drug. There are several detection kits that can show if a drink has been spiked with drugs like gamma-hydroxybutyric acid (GHB) and ketamine but there are no commercially available sensors to detect GBL.

http://www.rsc.org/chemistryworld/2013/06/date-rape-drug-sensor-gamma-butyrolactone

read also

Fernando Patolsky and Michael Ioffe of Tel Aviv University developed a sensor that, when dipped into a drink, will instantly detect the presence of a drug such as GHB, ketamine, or Rohypnol.

Date rape drug sensor

more info on other drug

Ketamine

Predatory drugs or date rape drugs are responsible for the creation of the most dangerous and pathologic environment that exists around drug use and drug abuse. Predatory drugs are a general class of drug that are primarily used to “render the victim incapable of resisting sexual advances”. (U.S. DEA)

This statement does not imply that the drug makes a person desire sexual activity, but quite the opposite. Predatory drugs leave the victim helpless, possibly unconscious, but certainly without any memory of a crime being committed against him/her. It can not be emphasized enough that giving someone a predatory drug is not only morally reprehensible it is also a serious criminal act. Illicit use of date rape drugs involve some of the most pathologic criminals who are involved with our justice system.

Street Names: Special K, K, Roofi, Sleepy
Misspellings: Ketamene, Ketimane, Rohipnol, Rophinol

What is Date Rape Drug Addiction?

So called date rape drugs are also found at rave parties, clubs, college parties, and even in high school social environments. They are potent drugs that can cause serious health problems, developmental problems, overdose and death. To further complicate the effects of these drugs, many are produced in illegal labs. Illicit production of drugs means there is no quality control standards. The lack of quality control standards can greatly diminish the purity of the drugs and leaves the user vulnerable to harsh chemicals and possibly overdose. Most of the chemicals found in date rape drugs are not intended for human consumption.

The number of drugs that are considered predatory drugs is increasing. To date, the most commonly used are:

  • GHB – GBH’s chemical name is gama hydroxybutyrate and is currently a
    DEA

    schedule 1 drug that has central nervous system depressant effects.

  • GBL/1 – GBL is a pro-drug of GHB and produces the same effects.
  • 4-BD – The chemical name of 4-BD is 1,4-Butanediol and is used industrially as a solvent. When taken recreationally, it produces the same effects as GHB.
  • Ketamine – Ketamine, or special K, as it is known on the streets, is a type of anesthetic known as a dissociative anesthetic and is approved for human and veterinarian use. When taken recreationally, it produces euphoria and hallucinations.
  • Rohypnol – The generic name of Rohypnol is flunitrazepam and it is marketed as a potent hypnotic, sedative, and it produces amnesia. It is in the class of drugs known as benzodiazepines.

Some of these drugs are made from industrial strength floor cleansers, lye, and Dranno and can cause brain damage.

Signs and Symptoms Date Rape Drugs Addiction

The regular use of drugs such as GHB/GBL used to lower inhibitions can create significant side effects. The most common side effects produced by the recreational use of date rape drugs are:

  • Psychosis and severe agitation requiring self-protection procedures and sedation
  • Mild tachycardia (increased heart rate) and hypertension
  • Neurologic effects, including prolonged delirium
  • Hallucinations
  • Diaphoresis (profuse sweating), nausea, and vomiting
  • Overdose, coma, and death

Because of the memory loss associated with these drugs, the user can be prone to use again and again without memory of severe side effects. Once used regularly, date rate drugs could also lead to serious withdrawal symptoms. These withdrawal symptoms will require medical attention and medication.

Beyond the physical dependence an emotional dependence can quickly develop. Once regular use begins an addict can experience personality changes which may result in aggressive behavior, a disregard for authority, a disregard for personal safety, risky sexual behavior, a loss of boundaries, financial difficulties, problems at school or work, a change in friends, and the loss of interest in normal activities.

No one plans on becoming an addict but the power of drugs on the brain’s functioning, accompanied by the alterations in the neuroreceptors, drives the addiction process. It is not about choice or desire once the body’s systems have been affected. Date rape drugs or predatory drugs are extraordinarily powerful both in their addictive qualities and the serious, negative, health consequences that accompany regular use.

TOSEDOSTAT CLINICAL TRIALS


Tosedostat

Benzeneacetic acid, α-[[(2R)-2-[(1S)-1-hydroxy-2-(hydroxyamino)-2-oxoethyl]-4-methyl-1-oxopentyl]amino]-, cyclopentyl ester, (αS)-

Cyclopentyl (2S)-({(2R)-2-[(1S)-1-hydroxy-2-(hydroxyamino)-2-oxoethyl]-4-methylpentanoyl}amino)(phenyl)acetate

[238750-77-1]

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today issued the following statement regarding the notification of the U.S. Food and Drug Administration (the “FDA”) partial clinical hold on tosedostat (IND 075503), the Company’s aminopeptidase inhibitor under development for the treatment of blood-related cancers, that is being studied in an investigator-sponsored trial and not by CTI. CTI’s primary development programs are the ongoing Phase 3 trial of pacritinib, the Company’s JAK2/FLT3 inhibitor being evaluated for patients with myelofibrosis, and the post-approval commitment study of PIXUVRI®(pixantrone).

http://www.heraldonline.com/2013/06/25/4972677/cti-issues-statement-regarding.html

VIVUS Announces SPEDRA (avanafil) Approval in Europe


File:Avanafil.svg

AVANAFIL

June 26, 2013

VIVUS, Inc. today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA(TM) (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013.
SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012.

About Avanafil

STENDRA, or avanafil, is approved by the FDA for the treatment of erectile dysfunction, or ED, in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries.

VIVUS is currently in discussions with potential partners to commercialize STENDRA in the United States and other territories throughout the world.

It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.Stendra.com.

EU OKs Nuedexta for PBA


Avanir Pharmaceuticals, Inc. today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.

http://www.pharmalive.com/avanir-pharmaceuticals-announces-european-approval-of-nuedexta

NUEDEXTA is an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination.

Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)- hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. The structural formula is:

structure1

Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-ol, 6’-methoxy- (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. The structural formula is:

structure2

The combination product, NUEDEXTA, is a white to off-white powder.  NUEDEXTA is available for oral use as NUEDEXTA which contains 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate. The active ingredients are dextromethorphan hydrobromide monohydrate USP and quinidine sulfate dihydrate USP.Inactive ingredients in the capsule are croscarmellose sodium NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, lactose monohydrate NF, and magnesium stearate NF.

 

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