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
Tamsulosin DRS is a new powder-like formulation containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCI) capsules. FLOMAX® is indicated for the treatment of BPH also known as enlargement of the prostate. Tamsulosin is a selective alpha1 blocker specific to receptors located in prostate and bladder smooth muscle. Symptoms associated with BPH occur because of increased prostate and bladder smooth muscle leading to constricted urinary flow, urinary retention, urinary infection, kidney damage and a life threatening blood infection called urosepsis. Blocking these receptors relaxes smooth muscle resulting in improved urinary flow and reduction of BPH symptoms. As stated in the FDA approved package insert, FLOMAX® capsules should not be crushed, chewed or opened, because they cannot be reliably absorbed into the bloodstream. Men with high FLOMAX® drug levels in their bloodstream are placed at risk for postural hypotension (sudden drop in blood pressure upon standing that can lead to fainting) and consequently such men may not continue to treat their BPH with FLOMAX®. Tablets and capsules are problematic for approximately 15% of men over the age of 60 who have difficulty swallowing tablets and capsules and the up to 60% of men in long term facilities who have difficulty swallowing tablets and capsules because of certain medical conditions, including degenerative neurological diseases like Parkinson's or having suffered a stroke. Not being able to take alpha1 blockers for BPH because of difficulty swallowing tablets and capsules, may lead to an increased risk of acute urinary retention, urinary catheterization, urosepsis and death. Because Tamsulosin DRS is a new proprietary powder-like formulation containing the active pharmaceutical ingredient in FLOMAX®, it would provide a more convenient and reliable way to deliver therapeutic levels of tamsulosin to men who have difficulty swallowing tablets and capsules.
About Veru Healthcare
Veru Healthcare (Veru) is a biopharmaceutical company focused on urology and oncology. Veru specifically focuses on the development and commercialization of pharmaceutical products that qualify for FDA's 505(b)(2) regulatory approval pathway, which is designed to allow for potentially expedited regulatory approval based on a previously established safety and efficacy profile of the product. Veru is developing products under the 505(b)(1) pathway as well, which is the traditional new drug application (NDA) pathway. The company is currently developing prescription products for benign prostatic hyperplasia (BPH or enlarged prostate), hot flashes associated with cancer treatment, male infertility and novel chemotherapies for a variety of cancers, including prostate, metastatic breast and ovarian. In addition, the company sells the FC2 Female Condom® (now available by prescription in the US) and PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
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.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release that are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company's products are at an early stage of development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints; risks related to the costs and other effects of litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2016. These documents are available on the "SEC Filings" section of our website at www.veruhealthcare.com/investors.
Contact: Kevin Gilbert Veru Healthcare 312-366-2633 KGilbert@veruhealthcare.com Jules Abraham JQA Partners, Inc. 917-885-7378 jabraham@jqapartners.com
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