Latest Topiramate Stories

SILVER SPRING, Md., March 4, 2011 /PRNewswire-USNewswire/ -- New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care...

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants. At this meeting the FDA requested that VIVUS assess the...

MOUNTAIN VIEW, Calif., Dec. 14, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010. The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the...

MAPLE GROVE, Minn., Dec. 6, 2010 /PRNewswire/ -- Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers. These and other findings from the USL255 early development program were presented Sunday, Dec. 5, at the 64th annual American Epilepsy Society (AES) meeting in San Antonio, TX. USL255, developed by Upsher-Smith...

MOUNTAIN VIEW, Calif., Nov. 15, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that data on QNEXA®, an investigational drug candidate, will be featured in a poster presentation at the American Heart Association's Scientific Sessions, being held November 13-17, 2010 in Chicago, IL. Following are details about the presentation: American Heart Association Scientific Sessions 2010 The poster presentation session will occur on Wednesday, November 17, 2010, from 9:00 am to...

MAPLE GROVE, Minn., Nov. 9, 2010 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the addition of an open-label extension study to PREVAIL, its global Phase III clinical trial for USL255 (extended-release topiramate). An internally developed program for the adjunctive treatment of adult epilepsy patients with partial-onset seizures, USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available...

BURLINGTON, Mass., Nov. 4, 2010 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed primary care physicians (PCPs) and endocrinologists indicate that--if these therapies are approved for obesity--they will prescribe Orexigen Therapeutics/Takeda's Contrave (a fixed dose combination of naltrexone and bupropion), Arena Pharmaceuticals/Eisai's Lorqess (lorcaserin) and Vivus's...

MOUNTAIN VIEW, Calif., Oct. 28 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. The application seeks the approval to market QNEXA as an oral,...

A dozen new epilepsy drugs are giving doctors and patients more options, but making treatment decisions more complex, a Loyola epilepsy specialist reports in the journal Neurologic Clinics."Clinicians practice in an era of abundance of anti-epileptic drugs," Dr. Jorge J. Asconapé wrote. The new drugs provide "an opportunity to better meet the needs of more patients."Asconapé's article will appear in the November issue of Neurologic Clinics, now available online.Since...

MOUNTAIN VIEW, Calif., Oct. 21 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that data on QNEXA®, an investigational drug candidate, will be featured in two oral presentations at the 1st International Diabetes and Obesity Forum, being held October 21-23, 2010 in Athens, Greece. Following are details about the presentations: The 1st International Diabetes and Obesity Forum in Athens, Greece Both presentations will be made by Dr. Louis J. Aronne, MD, on Saturday October 23,...