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PHERIN BEGINS PHASE 2 CLINICAL TRIALS WITH PH94B
On February 1st, 2008, Pherin Pharmaceuticals announced that it has commenced Phase 2B clinical trials in the US of its proprietary drug PH94B, for the treatment of Social Anxiety Disorder (Social Phobia). PH94B is a low dose (nanogram) vomeropherin compound, delivered intranasally in spray form, which is being developed for the acute treatment in patients with Social Anxiety Disorder.
The Phase 2B clinical trial is an in-clinic, multi-center, randomized, double-blind, single-administration, placebo-controlled study in approximately 50 Social Anxiety Disorder patients, using validated psychometric scales. In a similar Phase 2A clinical trial, two doses of PH94B (800 nanogram, and 1600 nanogram) were evaluated against placebo in 40 patients. PH94B signifficantly improved the primary efficacy endpoints (social performance and social interaction anxiety) within 10-minutes post-administration. Secondary efficacy endpoints for the trial included additional anxiety response assessments and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period.
PH94B's mechanism of action is unique. It acts locally on 7-transmembrane receptors in peripheral nasal chemosensory neurons that connect to the hypothalamic-limbic areas of the brain. This mechanism of pharmacological action, the rapid onset of effect, and the excellent safety and tolerability profile already demostrated, make PH94B an interesting novel product candidate for the acute treatment of patients with Social Anxiety Disorder.
About Social Anxiety Disorder (Social Phobia)
The National Comorbidity Survey, a large scale epidemiological study in the United States recently reported that Social Anxiety Disorder is a remarkable common disorder with a lifetime prevalence rate of 13.3 % and a one-year rate of 7.9 %, placing it third among psychiatric disorders, behind substance abuse and depression. Approximately 40 million people in the United States have been diagnosed with Social Anxiety Disorder. Social Anxiety Disorder (i.e.: fear of speaking in public) occurs every time the patient is exposed to the social challenge. Of the estimated Social Anxiety Disortder sufferers, most patients are treated with conventional medications, some of which can produce cardiovascular side effects and/or have an insufficient therapeutic response.
About PH94B
PH94B is a Pherin’s proprietary compound, a drug belonging to a new class of psychotropic vomeropherins, administered intranasally in nanogram doses. In a Phase 1 dose-escalation clinical trial, doses ranging from 0.4 to 10 microgram were well tolerated and there were no serious adverse events reported.
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