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Weekly Drug News Round Up - July 18, 2012

Qsymia Gains Approval for Obesity Treatment

FDA approves the second new drug in three weeks for treatment of obesity Read More...

The fight against the obesity epidemic in the U.S gains another drug approval. In addition to Belviq (lorcaserin) approved in late June 2012, the U.S. Food and Drug Administration (FDA) has now approved Qsymia (phentermine and topiramate XR) as an adjunct to diet and exercise for weight control. Qsymia is indicated for long-term weight loss management in adults who are obese (body mass index > 30 kg/m2) or overweight (body mass index > 27 kg/m2) with co-morbidities such as hypertension, type 2 diabetes, or high cholesterol. Qsymia is classified as a Schedule IV controlled substance due to the phentermine component. The last diet drug to be approved prior to Belviq was Xenical (orlistat) in 1999.

Truvada Approved to Reduce HIV Risk

Risk Evaluation and Mitigation Strategy (REMS) program added to promote safe sex measures, adherence Read More...

The U.S. Food and Drug Administration (FDA) has approved the daily use of Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 infection in high-risk adults. The approval was based on data from placebo-controlled clinical trials demonstrating efficacy of Truvada in high risk HIV-negative men or transgender women who have sex with men (42 percent reduced risk of HIV infection), and in heterosexual couples with one HIV-infected partner (75 percent reduced risk of HIV infection). Truvada is also approved for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Brilinta Included in Updated Blood Thinner Guidelines

Brilinta can be considered for unstable angina, NSTEMI; both conditions carry high risk for death and recurrent heart attacks Read More...

New guidelines published this week in the journal Circulation state that Brilinta (ticagrelor), an antiplatelet blood thinner, can be considered for treatment of unstable angina (severe chest pain) and for treatment of a type of heart attack known as non-ST segment elevation myocardial infarction (NSTEMI). Patients receiving medical therapy such as aspirin or having artery-opening procedures can receive Brilinta or Plavix (clopidogrel). Those who are receiving a procedure but cannot take aspirin can use Effient (prasugrel). Patients only receiving drug therapy, and no procedure, should receive aspirin indefinitely and Brilinta or Plavix for at least 12 months.

New Colonoscopy Bowel Prep Regimen Approved

FDA approves Prepopik to aid adults in preparation for screening colonoscopy procedure Read More...

Colonoscopy bowel-cleansing preparations can be time-consuming and unpleasant, to say the least. The U.S Food and Drug Administration has approved a new, and possibly easier option for colon cleansing. Prepopik (sodium picosulfate, magnesium oxide and citric acid) is a combined stimulant and osmotic laxative that has a lower volume of active ingredient and a flexible dosing schedule. Powder doses are dissolved in five ounces of water and taken either as the preferred split-dose regimen the night before and day of the colonoscopy, or as the day-before regimen, which is taken in the afternoon and evening before the colonoscopy. Additional clear liquids are required. Common side effects with Prepopik included nausea, headache and vomiting.

Alzheimer’s Investigational Drug Shows Early Promise

Investigational agent mimics the effect of acetylcholine at receptor site instead of preventing acetylcholine breakdown Read More...

An investigational Alzheimer’s disease drug known as EVP-6124 is showing promise in Phase 2 clinical trials. EVP-6124, in the class called alpha-7 nicotinic agonists acts to augment the effects of acetylcholine, a neurotransmitter needed for brain memory and function. The study included 409 patients with mild to moderate Alzheimer’s disease receiving either Aricept (donepezil), Exelon (rivastigmine), or no treatment at study entry. Patients were randomized to receive either placebo or one of three doses of EVP-6124. Significant results were noted for all patient groups taking high dose EVP-6124, but stomach side effects were noted.