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NexMed gains FDA approval of Tolnaftate-D

BY Michael Johnsen

SAN DIEGO — NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company’s first over-the-counter antifungal drug, Tolnaftate-D.

NexMed USA’s Tolnaftate-D incorporates NexACT, a proprietary drug delivery technology that transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.

"This is the first approval by the FDA of a drug containing Apricus Bio’s NexAct drug delivery technology, and as such, is a very important milestone for us," said Bassam Damaj, chairman, president and CEO of Apricus Bio, NexMed USA’s parent company. "In particular, we believe this is a crucial validation of our technology. Our expectation is that this may represent just the first of many such OTC drugs containing our proprietary technology."

The active ingredient in the cleared OTC drug, tolnaftate, already is an approved antifungal agent, which can be sold as a cream, powder, spray or liquid aerosol, and is currently used to treat jock itch, athlete’s foot and ringworm. With the approval of this drug, DDAIP, the mainstay of the company’s NexAct technology, now is listed as an excipient in an approved drug and is part of the U.S. monograph. As such, DDAIP can be combined with active ingredients listed in the monograph to develop a greater number of OTC products.

"We have been working on obtaining such status for over eight months and we believe that the cleared antifungal drug containing DDAIP and tolnaftate may be the first of many such OTC drugs that we and our partners will market and sell," Damaj said. "In addition, being added to the monograph permits us to work with other companies in developing combinations of our NexAct technology with the potentially hundreds of active ingredients listed in the monograph and to develop their proprietary drugs using NexAct at the concentration used in our approved Tolnaftate-D OTC drug."

 

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Valeant completes Sanitas Group acquisition

BY Allison Cerra

MISSISSAUGA, Ontario — Canada-based drug maker Valeant Pharmaceuticals International has acquired a Kaunas, Lithuania-based specialty pharmaceutical company.

Valeant said it completed its acquisition of Sanitas Group, which operates in Central and Eastern Europe and Russia markets.

The deal, which initially was announced by Valeant in May, was valued at EUR314 million (about $450 million) in cash.

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Study: Diabetes, hypertension patients at risk of developing glaucoma

BY Allison Cerra

NEW YORK — Americans that suffer from diabetes and/or hypertension are at risk of developing a common type of glaucoma, according to researchers at the University of Michigan Kellogg Eye Center.

The study, led by Kellogg glaucoma specialist Joshua Stein and funded by the National Eye Institute, reviewed billing records of more than 2 million people that were enrolled in a managed care network. These subjects visited an eye care provider one or more times between 2001 and 2007. Based on the data collected, Stein and his fellow researchers discovered that diabetics had a 35% increased risk of developing open-angle glaucoma, while hypertension patients had a 17% increased risk of developing OAG. For people with both diabetes and hypertension, however, they faced an increased risk of developing OAG of almost 50%.

"Patients who have diabetes and hypertension are already known to be at elevated risk for eye conditions like diabetic retinopathy, a condition that harms the blood vessels in the retina," Stein said. "This study and others suggest that, for these patients, an increased likelihood of glaucoma is also a concern. This study reinforces the importance of regular eye examinations for patients at increased risk of glaucoma, including those with diabetes and hypertension."

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