Somaxon receives FDA feedback on Silenor OTC Regulatory Pathway
US-based Somaxon Pharmaceuticals has received FDA Feedback on Silenor OTC Regulatory Pathway.
Silenor is used for the treatment of insomnia characterized by difficulty with sleep maintenance.
According to the company, FDA provided clinical and regulatory guidance is believed to help develop an OTC label that is tailored to Silenor's clinical profile and differentiated from other OTC sleep products.
Silenor's characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product, the company claims.