viewApricus Biosciences Inc

Apricus Biosciences receives FDA approval for third over-the-counter drug


Apricus Biosciences (NASDAQ:APRI) announced Wednesday it has received FDA approval for an over-the-counter (OTC) topical cream - its third clearance this month, sending its shares up as the company expands its OTC drug platform.

The drug, called Diphenhydramine-D, uses the company's NexACT technology. Intended to treat itching associated with insect bites, and other minor skin irritations, it contains diphenhydramine hydrochloride, a topical analgesic, or painkiller, and zinc acetate, a skin protectant.

The NexACT technology, which the company has used in two previous FDA-approved over-the-counter drugs, temporarily loosens skin cells, allowing for the drugs to be easily absorbed into the body.

New Jersey-based Apricus' shares on the Nasdaq exchange spiked 9.93% as of 1:19 pm EDT, trading at $4.87.

On August 18, Apricus received approval for its anti-fungal over-the-counter drug, Tolnaftate-D, and on not even a week later, it received approval for Hydrocortisone-D, an over-the-counter anti-itch drug. Both of these products used the NexACT technology.

"This latest clearance from the FDA of our third OTC drug containing our proprietary NexACT drug delivery technology, illustrates the progress we have achieved in a relatively short period of time toward building out our OTC Consumer Healthcare Division, and puts us one step closer to being able to provide a full-line of OTC products in the topical area," said Apricus president and CEO, Dr. Bassam Damaj.

"As such, we will continue to seek clearance for a number of additional OTC drugs in order to further expand this division and maximize the flexibility of our proprietary technology platform.

"In addition, we will be seeking partners with established distribution channels to partner with and commercialize these products."

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