Seelos Therapeutics Inc (SEEL)

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Apricus Bio Receives FDA Guidance on Phase 3 Study Design for RayVa™ Treatment for Raynaud’s Syndrome, Secondary to Scleroderma

Date : 09/21/2010 @ 3:11PM
Source : Business Wire
Stock : Apricus Biosciences (APRI)

http://ih.advfn.com/p.php?pid=nmona&article=44463472&symbol=N^APRI

Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud’s syndrome secondary to scleroderma. The Company met with FDA officials, including the Director of the Cardiovascular Division, in an effort to gain a clear and defined clinical path to support an application for the approval of RayVa. In the meeting, the FDA officials agreed with the Company on the clinical endpoints and agreed to receive a Phase 3 Special Protocol Assessment (“SPA”) clinical trial protocol for review. The Company is currently working to finalize and submit the Phase 3 SPA protocol, which the FDA will then have 30 days to review before human clinical studies are allowed to commence.

Raynaud's syndrome is a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress. Patients with Raynaud’s syndrome secondary to scleroderma typically have more severe complications, including digital ulcers. The prevalence of Raynaud's syndrome in the general U.S. population is estimated to vary from 4–15%. Females are seven times more likely to develop the condition than men. For most patients, Raynaud’s syndrome is an inconvenience. However, chronic recurrent cases of Raynaud’s syndrome can result in atrophy of the skin, subcutaneous tissues and muscle. In rare cases, it can cause ulceration and ischemic gangrene.

Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, “We are currently in the process of completing and submitting the final protocol for this trial. We believe that our success in obtaining approval to submit a Phase 3 SPA protocol to the agency further demonstrates the favorable safety profile of NexACT as observed in our clinical trials conducted to date. We now look forward to pursuing and commencing discussions for potential development partners for RayVa in the months to come with the objective of finding a development partner who will help to fund the expected costs of the RayVa study.”

About Apricus Biosciences

Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com. (Apricus Bio was previously named NexMed, Inc. The corporate name was changed in September 2010 in recognition of the evolution and expansion of the Company’s business.)

Forward-Looking Statement Safe Harbor

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including but not limited to its ability to replicate pre-clinical results in human clinical trials, enter into partnership agreements for the Company’s drug candidates or technologies, and obtain regulatory approval for any product candidates in development. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC’s website or without charge from the Company.