Transcept initiates enrollment in TO-2061 Phase 2 study for treatment resistant obsessive compulsive disorder

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced the first patient has been enrolled in a Phase 2 clinical study to evaluate TO-2061 as an adjunctive treatment for obsessive compulsive disorder (OCD) in patients who have responded inadequately to currently approved treatments. OCD affects 1 to 2 percent of the United States adult population and can significantly impair the lives of patients and their families. Approximately 50 percent of patients do not respond adequately to standard first-line treatment with currently approved OCD medications, including the selective serotonin re-uptake inhibitors (SSRIs) and the tricyclic agent, clomipramine. There is no FDA approved augmentation therapy for these treatment resistant patients.

TO-2061 is a low dose formulation of ondansetron, a serotonin subtype 3 (5-HT3) receptor antagonist. Ondansetron has an established history of clinical use as a safe and effective treatment for nausea and vomiting induced by chemotherapy, radiation therapy and surgery, for which a typical daily dose is 16 mg to 24 mg. Transcept is studying ondansetron at reduced total daily doses of 1.0 mg to 1.5 mg as an adjunctive treatment of OCD.

"Approximately one half of OCD patients do not respond to the approved first-line therapies, and there is no FDA-approved treatment for this population of non-responders," said Eric Hollander, MD, Clinical Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, and principal investigator for the study. "While atypical antipsychotics are often used as a second-line treatment, these drugs are not approved by the FDA for OCD therapy, are associated with undesirable weight gain and metabolic effects, and benefit only about one-third of treatment resistant OCD patients. A new therapeutic to help OCD patients who inadequately respond to approved OCD medications has the potential to address an important unmet medical need."

"The initiation of this Phase 2 study marks a significant milestone in the advancement of our second internally developed product candidate," said Glenn A. Oclassen, President and Chief Executive Officer of Transcept. "We were encouraged by the outcome of two open-label studies of low doses of ondansetron in treatment resistant OCD, and now seek to confirm these results in a double-blind, placebo-controlled trial."