Somaxon - SOMX denied - try again

* Says letter did not raise any clinical safety issues
* Co says FDA has requested for amended REMS
* Co intends to schedule meeting with FDA for guidance
* Shares tank 71.7 pct

Dec 7 (Reuters) - Somaxon Pharmaceuticals Inc said U.S. health regulators declined to approve its insomnia drug Silenor for the second time this year, sending its shares down 72 percent before the bell.
The company had previously received a complete response letter in February from the U.S. Food and Drug Administration, which raised issues regarding efficacy data. [ID:nBNG439722].
Somaxon resubmitted the new drug application (NDA) for Silenor in June.
In the most recent complete response letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy.
The letter did not raise any clinical safety issues but the FDA has requested the company submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product, in any resubmission, the company said.
Somaxon said it intends to schedule a meeting with the FDA to seek specific guidance because the most recent complete response letter did not contain any specific requirement to conduct any additional clinical work or other specific guidance.
Shares of Somaxon were trading at $1.00 before the bell. They had closed at $3.53 Friday on Nasdaq.