"These articles detail Phase 3 clinical data demonstrating that doxepin showed significant improvements compared to placebo on multiple efficacy endpoints relating to insomnia, with a favorable safety and tolerability profile," said Thomas Roth, PhD, chief, division head, Sleep Disorders & Research Center, Henry Ford Hospital, and an author on both articles. "This data, together with the remainder of the data from Somaxon’s clinical program, suggests that Silenor is an important option available for the management of insomnia patients."
The article entitled "Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia" is currently available online and is expected to be published in Sleep in the next 2 months, the company reports. Somaxon’s other article that has been accepted for publication, entitled "Efficacy and Safety of Doxepin 6 mg in a Model of Transient Insomnia," is expected to be published in Sleep Medicine in the next 3 months.
"The acceptance of these articles for publication is another milestone in our commercialization plan for Silenor as we look forward to an October launch," said Richard W. Pascoe, Somaxon’s president and CEO. "The articles, which describe Silenor’s safety and efficacy in the elderly and adult insomnia populations, together with others that we hope to have published in the future, will serve to educate healthcare providers on the comprehensive data that resulted from our Silenor clinical program."