Somaxon Pharmaceuticals Inc. got approval for its insomnia drug Silenor after three tries from the FDA. The company had initially sent their drug application as early as January, 2008 which eventually got declined. Somaxon resubmitted its application on January 21, 2010, which was considered as Class 1 resubmission with a two-month review cycle resulting in a decision date by March 21, 2010.
Silenor has not been designated as a controlled substance by the U.S. Drug Enforcement Administratio
The Almorexant insomnia drug from Actelion seems to be far from safe for now. After late-stage trials showed unspecified safety concerns, this drug which was supposed to be another medical alternative may not be suitable until they pinpoint the real safety constraint surrounding this sleep drug. More data was reportedly needed and unless that issue has been ironed out, sleep deprived individuals may as well avoid the sleep drug for now to avoid health complications that may be brought about.
Several safety observations had been made in results over 16 days from the Phase III
For the second time in a row the Silenor drug for Insomnia has been declined. Apparently the drug did not meet the approval standards for efficacy though no clinical issues were being placed in question. The FDA has requested the company to submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product.
Apparently this has been affecting the share value of the company which has dropped by more than 60%. The FDA declined to approve the drug back in February after citing concerns relating to heart health were t
