HEALTH

FDA clarifies LibiGel requirements for BioSante

BY Michael Johnsen

LINCOLNSHIRE, Ill. BioSante Pharmaceuticals Tuesday morning revealed that it has received clarity from the Food and Drug Administration on key FDA requirements for the development and approval of LibiGel in the treatment of female sexual dysfunction.

Presently, there are no pharmaceutical treatments for FSD and only one over-the-counter solution on the market.

BioSante met with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III (earlier this summer. According to BioSante, the primary focus of the meeting was BioSante’s LibiGel safety study protocol to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA.

“We are quite gratified by the outcome of our communications with the FDA,” stated Stephen Simes, BioSante’s president and chief executive officer. “We were confident that we had submitted a proposal that provided the depth and scope of study requested by the FDA. The agreement with FDA has reaffirmed our long-held belief that development of LibiGel could be both reasonable and affordable from both the financial and timeline aspects. We have received written FDA meeting minutes that provide us with a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. In the U.S., no pharmaceutical product is approved for the treatment of FSD making this a truly underserved market. BioSante is committed to the development of LibiGel which ultimately may be the first product approved by the FDA for this treatment in the U.S.”

In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. A new drug application can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval, BioSante will continue to follow the women enrolled in the study for an additional four years.

If successful with its BioSante, the resulting approval will raise awareness around FSD not only for LibiGel as a prescription solution, but also for Helm Pharmaceutical’s OTC remedy Vibrel.

Vibrel works through its transdermal delivery system of niacin, an essential B vitamin known for its vasodilation properties. The effects of the niacin are realized through the GlycoTransDelivery System, a proprietary structural matrix that ensures the stability and tolerability of the compound, increases blood flow to the genitals, adds lubrication and creates a sense of warmth.

Vibrel works through its transdermal delivery system of niacin, an essential B vitamin known for its vasodilation properties. The effects of the niacin are realized through the GlycoTransDelivery System, a proprietary structural matrix that ensures the stability and tolerability of the compound, increases blood flow to the genitals, adds lubrication and creates a sense of warmth.

Helm Pharmaceuticals has doubled Vibrel’s distribution in the past year (Vibrel is expected to reach 15,000 doors of distribution by year’s end) and plans to continue differentiating its product among OB/GYN’s as a product that helps alleviate FSAD as opposed to being just a personal lubricant.

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Bodee recalls Zencore after FDA finds undeclared drugs in chemical analysis

BY Michael Johnsen

CENTURY CITY, Calif. Bodee last month voluntarily recalled all of the company’s supplement product sold under the name Zencore Tabs after being informed by representatives of the Food and Drug Administration that lab analyses found the product contained potentially harmful, undeclared pharmaceutical ingredients.

FDA asserted that its chemical analysis revealed that one lot of Zencore Tabs contained aminotadalafil, an analog of tadalafil, the active ingredient in Eli Lilly’s Cialis erectile dysfunction medication.

FDA maintained that Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declared another lot of Zencore Tabs contained sildenafil, the active ingredient found in Pfizer’s Viagra, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil.

Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. The Zencore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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Vitamin Shoppe campaign to fight vitamin-A deficiency blindness

BY Michael Johnsen

NORTH BERGEN, N.J. The Vitamin Shoppe announced Wednesday it will begin accepting cash donations on behalf of Vitamin Angels in support of that agency’s campaign, Operation 20/20, as part of the vitamin retailer’s 30th anniversary celebrations.

“With our Anniversary Sale in-store, in our catalog and on the web, we know our loyal customers will join us in supporting this important initiative to end childhood blindness caused by [vitamin-A deficiency],” stated Tony Truesdale, president and chief merchandising officer of The Vitamin Shoppe.

Vitamin Angels is committed to eliminating childhood blindness caused by vitamin-A deficiency by the year 2020. Operation 20/20 is the first major step in this global campaign, which launched this year in 15 countries.

The Vitamin Shoppe is raising funds for Vitamin Angels in store at the register. Customers can donate $1 or more to the campaign and sign a Vitamin Angels paper angel to hang in the store. Any customer who donates $5 or more will receive a special Operation 20/20 wristband as a thank you. Online customers can also donate with each purchase at www.vitaminshoppe.com.

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