Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that the
U.S. Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) for Silenor® (doxepin) for the treatment of
insomnia characterized by difficulty with sleep maintenance.
“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.”
Sleep maintenance difficulty, defined as waking frequently during the
night and/or waking too early and being unable to return to sleep, is
the most commonly reported nighttime symptom of insomnia. Silenor is
approved for the treatment of both transient (short term) and chronic
(long term) insomnia characterized by difficulty with sleep maintenance
in both adults and elderly patients. In clinical trials, Silenor
demonstrated maintenance of sleep into the 7th and 8th
hours of the night, with no meaningful evidence of next day residual
effects.
Silenor has not been designated as a controlled substance by the U.S.
Drug Enforcement Administration (DEA) because of its demonstrated lack
of abuse potential. In addition, in the Silenor clinical development
program, no withdrawal effects or other adverse events were observed
that were indicative of physical dependence. In Somaxon’s market
research, abuse potential/risk of dependence was one of the most common
safety concerns cited by patients as a reason for not seeking
prescription treatment for insomnia, switching medications or
discontinuing treatment. The Silenor clinical trial program demonstrated
a favorable safety and tolerability profile, with the overall incidence
of adverse events comparable to placebo, a low discontinuation rate and
no evidence of tolerance, amnesia or complex sleep behaviors (e.g. sleep
driving, sleep eating).
“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,” said Richard W. Pascoe,
Somaxon’s president and chief executive officer. “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.”