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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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FDA Approves Brisdelle, paroxetine mesylate- First Non-Hormonal Treatment for Hot Flashes Associated with Menopause
June 28, 2013 –The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.
read all at
more info
PEXEVA® (paroxetine mesylate) is an orally administered psychotropic drug with a chemical structure related to paroxetine hydrochloride (Paxil®). It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4′-fluorophenyl)-3S-[(3′,4′-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C19H20FNO3•CH3SO3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is: paroxetine mesylate
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Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water.
Tablets
Each oval, film-coated tablet contains paroxetine mesylate equivalent to paroxetine as follows: 10 mg (white); 20 mg (scored, dark orange); 30 mg (yellow); 40 mg (rose). Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).
EP1286965B1
Tobramycin
Tobramycin is an aminoglycoside antibiotic derived from Streptomyces tenebrarius and used to treat various types of bacteria infections, particularly Gram-negative infections. It is especially effective against species of Pseudomonas.[1]
Tobramycin works by binding to a site on the bacterial 30S and 50S ribosome, preventing formation of the 70S complex. As a result, mRNA cannot be translated into protein and cell death ensues. Tobramycin is preferred over gentamicin for Pseudomonas aeruginosapneumonia due to better lung penetration.
Like all aminoglycosides, tobramycin does not pass the gastro-intestinal tract, so forsystemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin. The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis.[2] Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, such as Italy, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections : meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague).
Like other aminoglycosides, tobramycin is ototoxic: it can cause hearing loss, or a loss ofequilibrioception, or both in genetically susceptible individuals. These individuals carry a normally harmless genetic mutation that allows aminoglycosides such as tobramycin to affect cochlear cells. Aminoglycoside-induced ototoxicity is generally irreversible.
As with all aminoglycosides, tobramycin is also nephrotoxic, meaning it is toxic to thekidneys. This effect can be particularly worrisome when multiple doses accumulate over the course of a treatment or when the kidney concentrates urine by increasing tubular reabsorption during sleep. Adequate hydration may help prevent excess nephrotoxicity and subsequent loss of renal function. For these reasons parenteral tobramycin needs to be carefully dosed by body weight, and its serum concentration monitored. Tobramycin is thus said to be a drug with a narrow therapeutic index.
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Mass-spectrum of tobramycin |
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- “Tobramycin” (pdf). Toku-E. 2010-01-12. Retrieved 2012-06-11.
- “Nebulized Tobramycin in treating bacterial Sinusitis” (Press release). July 22, 2008. Retrieved 2009-12-06.
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.
- ^ “PRO051/GSK2402968”. Prosensa. Retrieved 29 October 2012
- ^ “A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD114044)”. ClinicalTrials.gov. Retrieved 29 October 2012.
Lyxumia approved in Japan for the treatment of type 2 diabetes
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Navidea starts clinical trial for Alzheimer’s diagnostic drug
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).
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Date rape drug sensor
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.
more info on other drug
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.
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.
VIVUS Announces SPEDRA (avanafil) Approval in Europe
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:
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:
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.
New Drug Approvals 