MIAMI, July 20, 2017 (GLOBE NEWSWIRE) -- Veru Healthcare (FHCO), a biopharmaceutical company focused on urology and oncology, today announced that the company has initiated the subject screening process for Stage 2 of its bioequivalence study of Tamsulosin DRS (Delayed Release Sachet), the company's novel, proprietary, slow release granular formulation of tamsulosin designed for the treatment of benign prostatic hyperplasia (enlarged prostate or BPH). In addition, the company has initiated manufacturing of the NDA required registration batch through its contract manufacturer, which will be used for FDA submission.
"Having reached the next and final stage of the required bioequivalence clinical study of Tamsulosin DRS in such a rapid timeframe positions us to make preparations for NDA submission," said Mitchell Steiner, MD, president and CEO of Veru. "Utilizing the 505 (b)(2) pathway for this, and many of our other prescription products, allows us to more rapidly get to the market, and bring treatments to those who need them sooner. Tamsulosin DRS is needed for the treatment of BPH for the 60% of men who are currently in long-term care facilities and the 15% of men the community who have difficulty swallowing pills."
The second stage of the bioequivalence trial is a 21-day single dose comparison of Tamsulosin DRS slow release granules with FLOMAX® capsules in 36 patients who have either fasted or eaten prior to dosing. In addition, the company's manufacturing partner has started the production of the commercial registration batch of Tamsulosin DRS required for FDA registration and product launch supply.
"Tamsulosin is the most widely prescribed medicine to treat symptoms of BPH, but is only currently available as a slow release capsule," said Ridwan Shabsigh, MD, professor of clinical urology, Weill-Cornell School of Medicine of Cornell University, New York, and a recognized expert in the treatment of BPH. "Many men who cannot swallow this capsule, whether because of stroke, Parkinson's disease or other limitations may be subjected to surgery, wear diapers, or have indwelling urinary catheters. As a slow release granules formulation, Tamsulosin DRS has the potential to change these men's lives. It may also be taken on an empty stomach, which may aid in avoiding dizziness and hypotension potentially seen when the current formulation of the drug is taken on an empty stomach."
About Tamsulosin DRS
About Veru Healthcare
The company's division, The Female Health Company, manages the Global Public Health Division, which is focused on the global public health sector FC2 business. This division markets the company's Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.
More information about Veru and its products can be found at www.veruhealthcare.com, www.PREBOOST.com and www.fc2femalecondom.com. For corporate and investor-related information about the company, please visit https://veruhealthcare.com/investors.
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Press Release Kari Sharp