ALGOS REPORTS ON EFFECTIVENESS OF MORPHIDEX IN CLINICAL TRIALS.Algos Pharmaceutical Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ALGO ALGO Algorithm ) has announced additional data from its Phase III clinical trials for its lead product MorphiDex(tm). As previously announced, a Phase III long-term, double-blind crossover study of 77 patients suffering chronic pain demonstrated that MorphiDex delivers equal analgesic activity at approximately one-half the narcotic dose of morphine. Elaborating on the results of that study, the company said today that patients received two weeks each of identically appearing capsules of morphine (30 mg) and MorphiDex (15 mg morphine and 15 mg dextromethorphan) and reported equivalent pain relief and global evaluations for the two treatments at mean daily morphine doses of 161.5 mg for morphine alone and 80.3 mg for MorphiDex (p<0.0001). Algos also stated that in a Phase III study involving the open label treatment of 250 chronic pain patients who were converted from their previous opiate opiate /opi·ate/ (o´pe-it) 1. any drug derived from opium. 2. hypnotic (2). o·pi·ate n. 1. to MorphiDex over a period of approximately two weeks, the patients rated MorphiDex significantly superior to their previous analgesic (p=0.0005). "MorphiDex's superior therapeutic profile results in dramatically higher patient satisfaction ratings over existing strong analgesic products," said John W. Lyle, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Algos. Algos submitted the MorphiDex New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) containing data from fourteen separate studies involving more than 1,500 patients. Algos Pharmaceutical Corporation, based in Neptune, New Jersey Neptune, New Jersey can refer to:
abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. will independently review the data submitted. The FDA review process is an uncertain one whose outcome cannot be guaranteed. There is no guarantee that the NDA filing will be approved by the FDA, or that the NDA will be accepted or approved without the need to file additional information or complete additional patient studies. Under the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. , the FDA has 12 months to review the accepted application and issue an Action Letter, which could be a deficiency or an approval. Resubmissions in response to a deficiency letter must be reviewed within two or six months depending on whether or not "substantial review work" is required. For more information, call (732)938-5959. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion