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European Commission Approves Stribild, a New Single Tablet Regimen for the Treatment of HIV-1 Infection

May 29, 2013 3:55 am / Leave a comment

May. 28, 2013– Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg),

a single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.

This approval allows for the marketing of Stribild in all 27 countries of the European Union.

AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet’s Disease in Japan

May 27, 2013 3:33 am / 3 Comments on AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet’s Disease in Japan

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Ranbaxy Laboratories gets tentative approval for HIV combination therapy

May 22, 2013 3:18 am / 6 Comments on Ranbaxy Laboratories gets tentative approval for HIV combination therapy

pic credit-www.pharmaceutical-technology.com

http://www.allfordrugs.com/2013/05/22/ranbaxy-laboratories-gets-tentative-approval-for-hiv-combination-therapy/

http://www.pharmaceutical-technology.com/news/newsranbaxy-laboratories-gets-tentative-approval-for-hiv-combination-therapy?WT.mc_id=DN_News

The US Food and Drug Administration has granted tentative approval for a fixed dose formulation of two generic drugs for use in combination with antiretrovirals.

Lamivudine and tenofovir disoproxil fumarate tablets, manufactured by India’s Ranbaxy Laboratories, will not be available for marketing in the US because of existing patent protections, but will be eligible for purchase elsewhere under the President’s Emergency Plan for Aids Relief programme.

lamuvudine

Lamivudine (2′,3′-dideoxy-3′-thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI).

It is marketed by GlaxoSmithKline with the brand names Zeffix, Heptovir, Epivir, and Epivir-HBV.

Lamivudine has been used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. It improves the seroconversion of e-antigen positive hepatitis B and also improves histology staging of the liver. Long term use of lamivudine unfortunately leads to emergence of a resistant hepatitis B virus (YMDD) mutant. Despite this, lamivudine is still used widely as it is well tolerated.

tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate (TDF or PMPA), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (NRTIs), which block reverse transcriptase, a crucial virus enzyme in human immunodeficiency virus 1 (HIV-1) and hepatitis B virus infections.

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

May 16, 2013 4:22 am / Leave a comment

May 15, 2013 — The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.

Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.

“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently.”

The safety and effectiveness of Simponi for ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment.

In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive Simponi or a placebo. Results showed that a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after six weeks compared with the placebo group.

In the second study, 310 patients with moderate to severe ulcerative colitis who were responders to Simponi were randomly assigned to receive Simponi or placebo. A greater proportion of Simponi-treated patients maintained clinical response through week 54, had clinical remission at both weeks 30 and 54 and, as seen during endoscopy, had improved appearance of the colon at both weeks 30 and 54 compared with the placebo group.

The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with Simponi are at increased risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.

Simponi is marketed by Horsham, Penn.-based Janssen Ortho Biotech, Inc

Golimumab (CNTO 148) is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor.

Golimumab was developed by Centocor and is approved in Canada and the United States as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.Golimumab is pending FDA approval for Ulcerative Colitis.

In the same year, Johnson & Johnson, the parent company of Centocor, also received an approval from European Medicines Agency (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab is marketed by Merck & Co, Inc. in Europe, pending final arbitration between J&J and Merck.

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs

May 16, 2013 4:16 am / 2 Comments on The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs

Cl 223Ra Cl

is the structure

http://www.ama-assn.org/resources/doc/usan/radium-ra-223-dichloride.pdf check out yourself

FDA Approves Xofigo for Advanced Prostate Cancer

May 15, 2013 — The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.

Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”

In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated the chemotherapy drug docetaxel.

Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.

The study was designed to measure overall survival. Results from a pre-planned interim analysis showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival.

The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).

Xofigo is marketed by Wayne, N.J.-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill., and Medivation, Inc. of San Francisco, Calif.

Eisai and Arena Pharmaceuticals have been given the go-ahead to launch their anti-obesity drug Belviq in the USA.

May 8, 2013 1:41 pm / 4 Comments on Eisai and Arena Pharmaceuticals have been given the go-ahead to launch their anti-obesity drug Belviq in the USA.

lorcaserin

may8, 2013

At long last, Eisai and Arena Pharmaceuticals have been given the go-ahead to launch their anti-obesity drug Belviq in the USA.

The US Food and Drug Administration approved Belviq (lorcaserin) last June chronic weight management in adults with a body mass index of 30 or greater, or adults with a BMI of 27 who have at least one weight-related condition such as hypertension, type 2 diabetes or high cholesterol. However, the agency said at the time that Belviq be classified by the US Drug Enforcement Administration as a scheduled drug, ie its potential for abuse needed to be evaluated.

This has held up a launch but now the DEA has placed Belviq into Schedule IV of the Controlled Substances Act, which means that the treatment has a low potential for abuse. In 30 days time, Eisai will make the drug available and the launch will trigger a $65 million milestone payment to Arena.

Arena will manufacture Belviq at its facility in Switzerland, and sell finished commercial product to Eisai for a purchase price starting at 31.5% of the Japanese drugmaker’s annual net product sales. The price increases on a tiered basis up to 36.5% exceeding $750 million and Arena is also eligible to receive $1.16 billion in purchase price adjustment payments.

Belviq can now compete against Vivus’ Qsymia (phentermine/topiramate) which was launched in September but has had disappointing sales, hit by reimbursement issues. Qsymia is also classed as Schedule IV by the DEA.

The move is clearly very good news for Arena which last week withdrew its marketing application for Belviq this side of the Atlantic. The European Medicines Agency’s Committee on Human Medicinal Products has expressed its concerns over potential cardiovascular risks and worries about tumours found in animal studies.www.arenapharm.com

www.eisai.com

Lorcaserin (APD-356, trade name upon approval Belviq, expected trade name during development, Lorqess) is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic. On 22 December 2009 a New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in the United States. On 16 September 2010, an FDA advisory panel voted to recommend against approval of the drug based on concerns over both safety and efficacy.In October 2010, the FDA stated that it could not approve the application for lorcaserin in its present form.

On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity like high blood pressure or type 2 diabetes.

On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who “have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol”.

On 07 May 2013, the US Drug Enforcement Administration has classified lorcaserin as a Schedule IV drug under the Controlled Substances Act.

FDA Approves Procysbi for Nephropathic Cystinosis

May 1, 2013 2:54 am / 7 Comments on FDA Approves Procysbi for Nephropathic Cystinosis

CYSTAGON® (cysteamine bitartrate) structural formula illustration

Cysteamine bitartrate

April 30, 2013 — The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.

Cystinosis is a rare genetic condition that affects an estimated 500 patients in the United States and about 3,000 patients worldwide. Fatal if not treated in early childhood, cystinosis causes a protein building block called cystine to build up in every cell of the body. The buildup of cystine causes kidney problems, which can cause the body to lose too much sugar, proteins and salts through the urine. Cystinosis may lead to slow body growth and small stature, weak bones and developing and worsening kidney failure. There are three types of cystinosis, the most severe being nephropathic cystinosis, which severely damages the kidneys.

Currently the FDA approved drugs used to treat cystinosis include Cystagon (cysteamine bitartrate), an immediate-release tablet that was approved in 1994, and Cystaran (cysteamine ophthalmic solution) eye drops, approved last year to treat corneal cystine crystal accumulation.

Procysbi is a delayed-release capsule intended for patients ages 6 years and older. While Cystagon is taken every six hours around the clock to control cystine levels, Procysbi is a long-acting formulation that is taken every 12 hours.

“Procysbi is the only delayed-release product approved by FDA to treat nephropathic cystinosis, offering patients with this rare disease an important new treatment option,” said Andrew E. Mulberg, M.D., deputy director, Division of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research, FDA.

The major study supporting Procysbi’s safety and effectiveness involved 43 adult and pediatric patients with nephropathic cystinosis. Patients were randomly assigned to receive Cystagon or Procysbi for three weeks before being switched to the other product for an additional three weeks. Blood testing showed Procysbi was as effective as Cystagon in controlling cystine levels.

The most common side effects in patients treated with cysteamine products include nausea, bad breath, abdominal pain, constipation, indigestion or upset stomach, headache, drowsiness and dizziness. Other uncommon but serious side effects include ulcers or bleeding of the stomach or intestine, altered mental state, seizures, severe skin rashes and allergic reactions.

Procysbi is marketed by Novato, Calif.-based Raptor Pharmaceuticals. Cystagon is marketed by Canonsburg, Pa.-based Mylan Inc. Cystaran is marketed by Gaithersburg, Md.-based Sigma-Tau Pharmaceuticals, Inc.

FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

May 1, 2013 2:50 am / 6 Comments on FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

tocilizumab

April 30, 2013

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA.

PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, a chronic disease of childhood.¹ JIA affects approximately 100 in every 100,000 children² of which PJIA accounts for around 30 percent.³ PJIA is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.³

“Polyarticular juvenile idiopathic arthritis is a rare debilitating condition in children that worsens over time,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased to offer Actemra to doctors and parents of children aged two or older to help improve the signs and symptoms of this often painful disease.”

This FDA approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years. The EU Committee for Medicinal Products for Human Use (CHMP) also announced a positive opinion for this indication on Friday, April 26. The final approval from the European Medicines Agency (EMA) is expected this summer.

The expanded indication for Actemra was based on positive data from the Phase III CHERISH study in children with PJIA, which had an open label phase, followed by a randomised double-blind placebo-controlled withdrawal phase. The study demonstrated that patients treated with Actemra experienced clinically meaningful improvement in signs and symptoms of PJIA. A total of 91 percent of patients taking Actemra plus MTX and 83 percent of patients taking Actemra alone achieved an ACR 30 response at week 16 compared to baseline. In the randomised double-blind placebo-controlled withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared to placebo-treated patients [26 percent (21/82) vs. 48 percent (39/81)].

The safety data collected to date for Actemra in PJIA patients is consistent with that observed in previous studies in Actemra-treated patients.⁴ In the CHERISH study, infections were the most common adverse events (AEs) and serious adverse events (SAEs) over 40-weeks. Laboratory abnormalities known to occur with Actemra were also observed in this study, including decreases in white blood cell counts and platelet counts, and elevation in ALT and AST liver enzyme levels.

About Actemra (tocilizumab)

Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive Actemra clinical development programme included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older who have responded inadequately to previous therapy with MTX.

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.

FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

April 30, 2013 2:59 am / 5 Comments on FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

April 29, 2013

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation,” said Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA. “Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.”

Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.

Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to minimize the risk of transmitting viral and other diseases. The FDA approval of Kcentra was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra was demonstrated to be similar to plasma in terms of the ability to stop acute major bleeding.

The drug is manufactured by CSL Behring, Marburg, Germany.

FDA Approves Amitiza [lubiprostone] for Opioid-Induced Constipation

April 24, 2013 3:14 am / 3 Comments on FDA Approves Amitiza [lubiprostone] for Opioid-Induced Constipation

7-[(1R,3R,6R,7R)-3-(1,1-difluoropentyl)-3-hydroxy-
8-oxo-2-oxabicyclo[4.3.0]non-7-yl]heptanoic acid

Lubiprostone

136790-76-6 cas no

FDA Approves Supplemental New Drug Application for AMITIZA® (lubiprostone), the First Oral Treatment for Opioid-induced Constipation in Adults with Chronic Non-Cancer Pain

Apr. 23, 2013– Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Sucampo’s supplemental new drug application (sNDA) for Amitiza (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

AMITIZA^®

This is the third indication for Amitiza, which is also approved in the U.S. for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 mcg twice daily). There are more than 200 million prescriptions for opioid use in the U.S. annually, and a substantial number of these prescriptions are for non-cancer chronic pain. Scientific literature indicates that approximately 40-80% of patients taking opioids chronically for non-cancer pain report constipation.

Opioid-based medicines are widely used in the management of chronic pain, with OIC being a common adverse effect of chronic opioid use. Some patients may discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.

Amitiza is a specific activator of ClC-2 chloride channels in the intestinal epithelium. Amitiza, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.

This approval is based on results from Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids (among them morphine, oxycodone, and fentanyl) chronically for non-cancer pain, as well as a long-term, open-label safety study, which provides additional support for use in this population. Two of the Phase 3 studies met their overall efficacy endpoint, while a third Phase 3 study did not.

OIC is a common adverse effect of chronic opioid use. Binding of opioids to peripheral opioid receptors in the gastrointestinal tract results in absorption of electrolytes, such as chloride, and subsequent reduction in small intestinal fluid. In addition, activation of enteric opioid receptors results in abnormal GI motility. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements.

Takeda Pharmaceutical Co Takeda

Amitiza (lubiprostone) capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. Amitiza is also indicated for irritable bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice daily).

Lubiprostone (rINN, marketed under the trade name Amitiza) is a medicationused in the management of chronic idiopathic constipation and irritable bowel syndrome. It was approved by the U.S. Food and Drug Administration (FDA) for this purpose on 31 January 2006.

Lubiprostone is used for the treatment of chronic constipation of unknown cause and irritable bowel syndrome associated with constipation.

As of 20 July 2006, Lubiprostone had not been studied in children. There is current research underway to determine the efficacy in postoperative bowel dysfunction, and opioid-induced bowel dysfunction

“amitiza”. The American Society of Health-System Pharmacists. Retrieved 3 April 2011.
Sobrera, L. A.; Castaner, J. (2004). Drugs of the Future 29 (4): 336.

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European Commission Approves Stribild, a New Single Tablet Regimen for the Treatment of HIV-1 Infection

AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet’s Disease in Japan

Ranbaxy Laboratories gets tentative approval for HIV combination therapy

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs

Eisai and Arena Pharmaceuticals have been given the go-ahead to launch their anti-obesity drug Belviq in the USA.

FDA Approves Procysbi for Nephropathic Cystinosis

FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

tocilizumab

About Actemra (tocilizumab)

FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

FDA Approves Amitiza [lubiprostone] for Opioid-Induced Constipation

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