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news.Somaxon Pharmaceuticals (Somaxon) has received FDA approval for new drug application (NDA) of Silenor (doxepin) for the treatment of insomnia characterised by difficulty with sleep maintenance.
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Somaxon Pharma has said that Silenor has not been designated as a controlled substance by the US Drug Enforcement Administration (DEA) because of its demonstrated lack of abuse potential.
As result of the NDA approval for Silenor, Somaxon is expected to be required to make a $1m milestone payment to its licensor for Silenor pursuant to its existing license agreement.
Richard Pascoe, president and CEO of Somaxon, said: “The approval of Silenor represents an important milestone for Somaxon and will allow us to provide physicians and patients with a highly differentiated treatment option for insomnia.
“We believe that Silenor’s ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential uniquely positions Silenor for commercial success. Looking forward, we will continue to execute on our business strategy, focusing on seeking a US commercial partnership, building a US commercial presence and preparing to launch Silenor in the second half of 2010.”