PHARMACY

Snabes tapped as BioSante Pharmaceuticals vice president of clinical development

BY Diana Alickaj

LINCOLNSHIRE, Ill. BioSante Pharmaceuticals announced Michael Snabes as the company’s new vice president of clinical development, according to published reports.

Snabes will be responsible for the development of LibiGel, which is a testosterone gel for the treatment of female sexual dysfunction. Snabes has a history with BioSante as he served as medical consultant of BioSante since November 2005, where he focused on clinical and regulatory matters, according to published reports.

He is a board certified reproductive endocrinologist, and has a Ph.D. in physiology and reproductive endocrinology. According to published reports, he also played major role in the submission of BioSante’s New Drug Application Elestrin, which now has been approved fully by the Food and Drug Administration.

“We are very pleased that Michael has agreed to accept this position with BioSante,” said Stephen Simes, president and chief executive officer of BioSante. “Michael has been an important part of our clinical team for more than two years and his full-time involvement will help us to implement fully and accelerate our development of LibiGel in the treatment of FSD, specifically hypoactive sexual desire disorder in menopausal women.”

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FDA approves Alcon’s Patanase for nasal allergy symptoms

BY Adam Kraemer

HUENENBERG, Switzerland Alcon announced that the Food and Drug Administration has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

“We look forward to providing doctors the opportunity to prescribe Patanase to their patients who need and want a fast-acting nasal spray that quickly relieves symptoms,” said Kevin Buehler, Alcon’s senior vice president of global markets and chief marketing officer. “We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise.”

Clinical studies found that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in symptoms compared to the placebo nasal spray. Additionally, onset of action was evaluated in three studies, in which patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either Patanase or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Patanase nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of affect after dosing, which was statistically significant compared to the placebo spray.

“For patients who suffer every allergy season with symptoms that make life in those months miserable, Patanase offers relief beginning in minutes in a convenient steroid-free nasal spray,” said one study’s lead investigator, Eli Meltzer. “The fact that it works quickly is important. Patients in our fast-paced society want rapid improvement and relief from their nasal allergies.”

Patanase nasal spray, an extension to Alcon’s market-leading ocular allergy product line, will be available in May of this year.

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EPA sets up collection sites in eight states for used meds

BY Adam Kraemer

BUFFALO, N.Y. The Environmental Protection Agency, recognizing that trace amounts of pharmaceuticals are showing up in drinking water, has begun urging consumers living near any of the Great Lakes to bring their old medications to official collection centers.

The EPA is helping pay for more than 70 collection points in eight states that will take old medicine—along with electronic waste like computers, cell phones and televisions—from April 19 through April 27. The agency has set a goal of collecting 1 million pills during an Earth Day initiative aimed at the more than 30 million people who live around the Great Lakes, which are by far the largest source of fresh drinking water on the planet.

The collection sites are being established in New York, Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania and Wisconsin.

“We’re trying to raise public awareness on disposing of pharmaceuticals properly and we’ve had a very good response from communities on water districts. This is information that needs to get out there,” EPA spokeswoman Phillippa Cannon said Tuesday.

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