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Pherin Pharmaceuticals Reports Favorable Phase II Data Showing Clinical Benefits of Novel Intranasal Medication PH80 to Treat Symptoms of Premenstrual Syndrome (PMS).

* Intranasal Aerosol Treatment with 800 Nanogram PH80 up to Four Times Daily, During the Symptomatic Days of PMS Only, Shows Significant Efficacy, Distinct Improvement over Placebo and Symptoms Remission in Clinically Significant PMS

* No Adverse Events Reported, Excellent Safety and Tolerability Profile

* Phase III Program Investigating PH80 Now Being Implemented

* Approximately 80% of Women Ages 15 to 44 in the US Suffer from Symptoms of PMS

REDWOOD CITY, Calif. -- Pherin Pharmaceuticals, Inc. reports that recent clinical trial results from a Phase II study showed that PH80, a novel compound patented by Pherin Pharmaceuticals, administered intranasally in aerosol form demonstrated significant benefits in the treatment of symptoms of PMS. Based on the positive Phase II study results, Pherin Pharmaceuticals is programming a Phase III pivotal study to further evaluate PH80 benefits in patients with PMS.

The multicenter, double blind, placebo-controlled Phase II study involved 60 randomized patients with clinically significant PMS. Patients were randomized into one of two treatment groups: 800 nanogram PH80 up to four times daily during six consecutive days or placebo. The primary objective of the four-month study was to assess the efficacy of PH80 in treating the symptoms associated with PMS. Results show that during a six day treatment (critical days of PMS only) PH80 administered intranasally up to four times daily improved PMS symptoms significantly better than placebo (P< 0.05). The medication showed clinical efficacy to reduce premenstrual symptoms in 63% of patients as compared to placebo (44% only) during the treatment phase. Symptom remission was also significantly greater than placebo during the month following treatment with PH80 (P< 0.01).

PMS symptom scores from baseline and after treatment were assessed using validated psychometric scales. Clinical improvement in PMS symptom scores revealed significant change from baseline (P< 0.01) for Irritability and Persistent Anger; Difficulty Concentrating; Depression, Feeling Sad, Down or Blue, and Craving Foods and Increased Appetite and Overeating, among other symptoms.

Although not statistically significantly different from placebo for four-time daily PH80 (P=0.08) there was also improvement of Cramps with a 30% reduction in mean symptom score with PH80. The proportion of responders, defined as patients with at least 60% improvement in total PMS symptom score at the end of each treatment day compared to baseline, showed that 800 nanogram PH80 up to four times daily reached statistical significance (P< 0.05).

"These results are impressive and position PH80 favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require much higher dosing and have concurrent side effects," said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. "We are enthusiastic about sharing these data with companies that express interest in co-developing PH80 with us to advance our development program."

It is important that intranasal application up to four times-daily of PH80 during the critical days of PMS provides a significant and rapid improvement in symptoms, as well as a carry over symptom remission during the subsequent period. If the magnitude of benefits shown in this Phase II study is confirmed in the larger-scale Phase III study, intranasal PH80 could represent a major improvement in the way PMS will be treated in the future.

There were no adverse events reported associated with PH80 and the medication was well tolerated by the treated patients. We attribute these results to the unique formulation of PH80, which is based on our aerosol drug delivery technology.

Phase II Study Results

The Phase II study was conducted in three centers and in 60 patients to evaluate the effect of PH80 for the acute treatment of symptoms of PMS, as well as its safety and tolerability.

In the placebo-controlled phase, 60 patients were randomized to receive intranasally either 800 nanogram PH80 or placebo up to four times-daily during six consecutive days (critical days of PMS symptoms only). Fifty-six patients completed the study. The study showed that six-day treatment with intranasal PH80 provides significant improvement in symptom measures and remission in clinical endpoints in patients with PMS. Irritability, Difficulty Concentrating, Depression and Increased Appetite showed improvement significantly better than placebo and Physical Symptoms (Cramps) showed improvement after applying PH80 compared to the effect of placebo.

About PH80 and PMS

PH80 is the first in a new class of Pherin proprietary compounds called vomeropherins that modulate basal forebrain centers acting on peripheral chemosensory receptors in the nasal passages, and has a novel mode of action and a very good safety and tolerability profile different from all currently marketed PMS treatments. PH80 has been developed by and is proprietary to Pherin Pharmaceuticals.

In the US, more than 50 million women 15 to 44 years are estimated to suffer from PMS, which is one of the leading causes of impairment of social activities, family relationships and/or work.

The symptoms of PMS can include irritability, tension, fatigue, lack of energy, feeling out of control, aches, mood swings, swelling, bloating, craving foods, cramps, feeling sad and difficulty concentrating. These symptoms can have a significant impact on the patient's employment, social activities and overall quality of life.


This release contains certain forward-looking statements regarding Pherin Pharmaceuticals' business. Such forward-looking statements reflect the current views of Pherin Pharmaceuticals regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with PH80 to be materially different from any future results, performance or achievements expressed or implied by such statements.

About Pherin Pharmaceuticals

Pherin Pharmaceuticals has developed a family of leading and innovative proprietary compounds called vomeropherins that bind to peripheral chemosensory receptors in the nasal passages that affect the hypothalamus and the limbic system and induce proven behavioral, neuropsychiatric and neuroendocrine effects in humans. Among Pherin Pharmaceuticals extensive library of vomeropherins there are molecules being studied for their potential therapeutic application for the treatment of anxiety, depression, body weight management and improvement of cognitive performance.

Pherin Pharmaceuticals is the leader in the development of vomeropherins for more than 15 years, having pioneered for a number of years breakthrough discoveries of the behavioral and neuroendocrine effects of a large number of vomeropherins that can be administered airborne to the nasal passages in minuscule quantities (nanogram or low microgram range) and have proven good safety and tolerability and minimal side effects. Pherin's mission is to improve people's lives by pioneering novel healthcare products that make distinct improvement over other treatments.
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Publication:Business Wire
Date:Dec 21, 2006
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