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Pherin Pharmaceuticals Reports Favorable Clinical, Regulatory, and Intellectual Property Actions on Novel Intranasal Medication for Acute Treatment of Social Anxiety Disorder and Issuance of Patents in the U.S.A. and Other Major Countries
By: Marketwired .
Dec. 5, 2012 08:03 PM
LOS ALTOS, CA -- (Marketwire) -- 12/05/12 -- Pherin Pharmaceuticals announced today that a Phase II clinical trial showed that its proprietary compound PH94B demonstrated significant benefits in the acute treatment of symptoms of Social Anxiety Disorder (Social Phobia). Based on the positive study results, Pherin has met with the US Food & Drug Administration to plan a Phase III pivotal study of PH94B for the acute treatment of Social Anxiety Disorder. Also, Pherin has received Notification of Issuance from the US Patent & Trademark Office for its patent application covering the acute treatment of Social Anxiety Disorder with PH94B and similar allowances in the European Union, Japan, China and other major countries.
Phase II Study Results
"These results are impressive and position PH94B favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require chronic dosing and have concurrent side effects," said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. "We are enthusiastic about sharing data with interested companies to co-develop PH94B. If the magnitude of benefits shown in this Phase IIB study is confirmed in a larger-scale Phase III study, intranasal PH94B could represent a major improvement in the way Social Anxiety Disorder will be treated in the future."
There were no adverse events associated with PH94B and the medication was well tolerated. Pherin attributes these results to the unique formulation of PH94B.
About PH94B and Social Anxiety Disorder
Social Anxiety Disorder, also called Social Phobia, is reportedly the most common anxiety disorder, with a lifetime prevalence of 13-14%. Social Anxiety Disorder is characterized by a persistent and unreasonable fear of one or more social or performance situations, where the individual fears that he or she will act in a way or show symptoms that will be embarrassing or humiliating, leading to avoidance of the situations when possible and anxiety or distress when they occur. There are two types: generalized Social Anxiety Disorder, where the fears are related to both social and performance situations; and discrete Social Anxiety Disorder, where the fears are related to particular performance anxiety situations only, such as public speaking. These fears can have a significant impact on the person's employment, social activities and overall quality of life. Social Anxiety Disorder is commonly treated chronically with antidepressants, which have a slow onset of action and side effects that may make them unattractive to sufferers from Social Phobia. There are no acute treatments for generalized Social Anxiety Disorder; and the current acute treatments for discrete Social Anxiety Disorder are beta-blockers, which must be taken 30-60 minutes before the expected time of the performance situation and are associated with their own side effects.
Pherin is the leader in the development of pherines, having pioneered breakthrough discoveries of the behavioral and neuroendocrine effects of a large number of pherines that can be administered airborne to the nasal passages in nanogram or low microgram range. Pherin's mission is to improve people's lives by pioneering novel healthcare products that make distinct improvements over other treatments.
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