Biogen Idec (NASDAQ:BIIB) reported on Thursday the top-line results of EMPOWER, which was a Phase 3 trial evaluating dexpramipexole in people suffering from amyotrophic lateral sclerosis. The trial failed to meet its primary endpoint, which was a joint rank analysis of function and survival, and no efficacy was found in the individual components of function or survival. In addition, the trial indicated no efficacy in its key secondary endpoints. Other analyses of multiple subpopulations failed to show any efficacy among these groups and on these results, the firm discontinues its development of dexpramipexole in ALS.
Merck & Co. (NYSE:MRK) said that a combination tablet that contains the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval. The company which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin but has repeatedly failed in its endeavors to gain FDA clearance of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application submission was originally turned down by the FDA in 2009 and again in 2012.
On Thursday, Repros Therapeutics (NASDAQ:RPRX) said that top line results from its Phase 2 study of vaginally administered Proellex in the treatment of symptomatic fibroids imply that the 12 mg dose may provide clinical benefit to women suffering from symptomatic uterine fibroids. The firm intends to request an end of Phase 2 when it meets with the FDA as soon as practicable.
Zogenix (NASDAQ:ZGNX) announces positive single-dose pharmacokinetic results from the Phase 1 clinical trial of Relday, which is an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. Adverse events in the Phase 1 evaluation in patients diagnosed with schizophrenia were typically mild to moderate, and consistent with other risperidone products. Zogenix is a pharmaceutical firm that commercializes and develops products for the treatment of central nervous system disorders and pain.
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