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Latest Topiramate Stories

New Diet Pill Side-Effects Under Scrutiny By FDA Regulators
2012-02-20 09:36:10

A weight-loss drug currently under a second review from the Food and Drug Administration (FDA) is causing concerns that it may be responsible for birth defects and heart problems, according to documents released by the agency on Friday. The drug, developed by Vivus, was rejected by the agency in 2010, largely because of those risks. A committee of outside advisers to the FDA will meet this week to reconsider whether the drug, called Qnexa, should move forward in the approval process,...

2012-01-17 05:45:00

MOUNTAIN VIEW, Calif., Jan. 17, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the REVIVE study were published in The Journal of Sexual Medicine (JSM), a peer-reviewed journal with broad, multidisciplinary readership. REVIVE (TA-301) was a randomized, placebo-controlled, phase 3 study evaluating the safety and efficacy of avanafil, an investigational drug currently under review by the Food and Drug Administration (FDA) for the treatment of erectile...

2012-01-09 05:45:00

MOUNTAIN VIEW, Calif., Jan. 9, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa® contraindication for women of childbearing potential contained in the proposed label. Qnexa would remain contraindicated for women who are pregnant. A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs...

2012-01-04 05:45:00

MOUNTAIN VIEW, Calif., Jan. 4, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the Company will present at the 30th Annual JP Morgan Healthcare Conference. The VIVUS presentation will take place at the Westin St. Francis Hotel in San Francisco, CA on Monday, January 9, 2012 at 9:00 a.m. PT. A live webcast and 30-day archive of the presentation will be available at http://ir.vivus.com. About VIVUS VIVUS is a biopharmaceutical company developing...

2011-12-23 05:45:00

MOUNTAIN VIEW, Calif., Dec. 23, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on October 17, 2011 seeking approval to market Qnexa in the United States. The FDA accepted the NDA for review on...

2011-12-21 15:00:00

MOUNTAIN VIEW, Calif., Dec. 21, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced topline preliminary results from its retrospective study of medical claims data on oral clefts (OC) associated with topiramate exposure in utero. The study, known as FORTRESS for Fetal Outcome Retrospective TopiRamate ExpoSure Study, identified 1,945 mother-infant dyads exposed to topiramate either alone (monotherapy) or in combination with other antiepileptic agents (polytherapy) in the...

2011-12-21 07:00:00

BRANFORD, Conn., Dec. 21, 2011 /PRNewswire/ -- Marinus Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that its neurosteroid ganaxolone which is currently under study for the treatment of partial onset seizures (POS), reported positive data in the open-label extension follow up to the company's Phase 2 clinical trial. The data reflects the replication of the effects seen in the double-blind study. Patients who enrolled in the study demonstrated an...

2011-12-08 07:00:00

MOUNTAIN VIEW, Calif., Dec. 8, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership. The SEQUEL study evaluated the long-term efficacy and safety of Qnexa in 676 overweight and obese subjects with cardiometabolic disease. In addition to 10% sustained weight loss, the study also found that significantly more...

2011-12-07 05:45:00

MOUNTAIN VIEW, Calif., Dec. 7, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) announced that an oral presentation was given at the International Diabetes Federation's World Diabetes Congress, in Dubai, United Arab Emirates today. The presentation highlighted excess weight loss, improvement of glycemic parameters in diabetic patients with a BMI>35 and effects on diabetes status. This is the first World Diabetes Congress to be organized in the Middle East and North Africa Region -...

2011-12-05 09:00:00

<font size="2" face="Arial"> </font> MAPLE GROVE, Minn., Dec. 5, 2011 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. [http://www.upsher-smith.com] today announced the presentation of Phase 1 data showing that once-daily administration of USL255, a proprietary, extended-release (ER) formulation of the epilepsy medication topiramate, demonstrated linear dose-proportionality and, when compared to immediate-release (IR) topiramate administered twice-daily, an improved...