Apricus Biosciences Receives FDA Clearance to Begin Clinical Trial of RayVa for Secondary Raynaud's Phenomenon

SAN DIEGO, May 12, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application allowing the Company to initiate clinical testing of RayVa™, Apricus' product candidate for the treatment of Raynaud's phenomenon. The Company expects to commence a Phase 2a clinical trial and begin enrollment in the second half of 2014. RayVa combines alprostadil, a vasodilator, with Apricus' proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities. In a nonclinical model, the Company demonstrated topical administration of alprostadil cream to cold-challenge statistically improved blood flow by 30 minutes relative to placebo, as measured by Laser Doppler. The improvement in blood flow was maintained out to 90 minutes post-challenge.

"We are excited to bring our third product candidate into the clinic, expanding our development pipeline beyond sexual health, and leveraging our proprietary permeation enhancer technology, to address Raynaud's phenomenon secondary to scleroderma, a disease that affects an estimated 100,000 people in the United States1," said Richard W. Pascoe, Chief Executive Officer. "Secondary Raynaud's phenomenon disproportionately affects women and currently has no approved therapy in the United States, representing an unmet medical need. Patients suffering from secondary Raynaud's phenomenon are typically treated by just over 4,500 rheumatologists in the United States2, thus providing Apricus with a potential path to building a focused commercial organization in the future."

The randomized, double-blind, placebo-controlled, Phase 2a trial is expected to enroll approximately fifty patients with Raynaud's phenomenon secondary to scleroderma. Each patient will receive applications of placebo and doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics and temperature at the site of application in response to a cold challenge, as measured by Laser Doppler and thermography. Other endpoints include safety and pharmacokinetic assessments. The FDA has indicated that RayVa may qualify for priority review, given the unmet medical need and lack of approved products to treat secondary Raynaud's phenomenon. The FDA will determine if the RayVa New Drug Application qualifies for priority review following its submission, which could occur as early as 2017.

About Raynaud's Phenomenon

Raynaud's phenomenon is characterized by vasoconstriction in the hands, feet or other extremities, resulting in reduced blood flow and the sensation of pain, which can become severe. It is classified as either primary or secondary. Primary Raynaud's phenomenon, which is not associated with an underlying medical condition, refers to vasoconstriction associated with exposure to cold or stress. Primary Raynaud's phenomenon affects an estimated 3-5% of the US population, mostly women.3 Secondary Raynaud's phenomenon, with symptoms similar to primary Raynaud's phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.4 There are an estimated 100,000 adult patients with scleroderma in the US1, of which approximately 90% have secondary Raynaud's phenomenon4. Overall, there are approximately 500,000 adult patients with secondary Raynaud's phenomenon in the US.4,5

Approximately 80% of scleroderma patients are women.6 Both primary and secondary Raynaud's phenomenon disproportionately affects women.7 There is currently no approved therapy for Raynaud's phenomenon in the United States, representing an unmet medical need.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health. The Company's lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and will be commercialized by Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. The Company's second-generation Vitaros room temperature device is under development and is expected to enhance the product's commercial value. Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. The Company is currently seeking a strategic partner for Femprox. RayVa™, the Company's product candidate for the treatment of Raynaud's phenomenon, recently received FDA clearance to begin clinical studies. The Company intends to begin a Phase 2a trial with RayVa in the second half of 2014.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the timing of the commencement of a Phase 2a clinical trial for RayVa™, the size of the commercial opportunity for RayVa and the ability to build a focused commercial organization for RayVa. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of the Company, including, but not limited to: its ability to further develop its product candidate RayVa for the treatment of Raynaud's phenomenon, as well as the timing of such events; Apricus' ability to carry out clinical studies for RayVa, as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approvals for RayVa; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from the Company.

1 Barnes J and Mayes MD. Epidemiology of systemic sclerosis: incidence, prevalence, survival, risk factors, malignancy, and environmental triggers. Curr Opin Rheumatol 2012, 24:165–170. American College of Rheumatology (http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Scleroderma).

2 American Medical Association 2011.

3 Wigley FM. Raynaud's phenomenon. N Engl J Med. 2002; 347:1001–1008. Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525.

4 Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525.

5 2012 U.S. Census Bureau: State and County QuickFacts (http://quickfacts.census.gov/qfd/states/00000.html).

6 Gelber AC, Manno RL, Shah AA, Woods A, Le EN, Boin F, Hummers LK, Wigley FM. Race and Association With Disease Manifestations and Mortality in Scleroderma. Medicine 2013; 92: 191-205.

7 National Institutes of Health (http://www.nhlbi.nih.gov/health//dci/Diseases/raynaud/ray_risk.html).

Source: Apricus Biosciences, Inc.

Posted: May 2014

View comments

Hide
(web3)