Somaxon Pharma Silenor Receives FDA Approval

Somaxon Pharma claimed that Silenor binds with high affinity to histamine (H1) receptors. This is believed to be the mechanism by which Silenor promotes the maintenance of sleep. The mechanism of action is different from that of any other prescription medication currently approved for the treatment of insomnia.

Silenor clinical trial showed maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects. Additionally, it showed a favorable safety and tolerability profile.

Somaxon Pharma 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 Pharma, said: “The approval of Silenor represents an important milestone for Somaxon and is expected to allow us to provide physicians and patients with a treatment option for insomnia.

“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.”

Thomas Roth, chief, division head of sleep disorders and research center at Henry Ford Hospital, said: “The introduction of Silenor, a sleep promoting medication that works through the histamine system, provides the clinician an important addition to his armamentarium needed for the management of insomnia patients.”