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FDA Grants Fee Waiver for Tamsulosin DRS New Drug Application

-- Provides $2.4 Million for Drug Product Development --

MIAMI, March 22, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on urology and oncology, announced that the U.S. Food and Drug Administration (FDA) granted its application for a small business waiver of the drug application fee of approximately $2.4 million for the Company’s New Drug Application (NDA) for Tamsulosin Delayed Release Sachet (DRS).  This is the first in a series of NDAs that the Company is planning on submitting over the next two years. 

/EIN News/ -- Tamsulosin DRS is a new, proprietary, slow release oral granule formulation that addresses the large population of men who have benign prostatic hyperplasia (BPH) and who have dysphagia (difficulty swallowing tablets or capsules).

“FDA’s grant of the fee waiver frees up resources to further advance our drug development programs,” said Mitchell Steiner, M.D., President and Chief Executive Officer of Veru.  “We plan to file the NDA for Tamsulosin DRS during the current calendar year.”

About Tamsulosin DRS (Tamsulosin HCl extended release for oral suspension)

Tamsulosin DRS is a new granule 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 adrenoreceptor antagonist specific to receptors located in prostate and bladder smooth muscle. Symptoms associated with BPH occur because of a change in the functioning of the prostate and bladder smooth muscle that can lead to constricted urinary flow, urinary retention, urinary infection, kidney damage and a life-threatening blood infection called urosepsis. Blocking alpha1 adrenoreceptors relaxes smooth muscle resulting in improved urinary flow and reduction of BPH symptoms.

According to IMS Health sales data, FLOMAX® and their generics have 84% market share of the multi-billion-dollar alpha1 blocker market for BPH in the United States.  FLOMAX® and their generics are only available as slow release capsules for BPH. 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 dizziness. 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 68% 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 and Alzheimer’s disease 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 slow release granule formulation containing the active pharmaceutical ingredient in FLOMAX®, it would provide a more reliable way to deliver therapeutic levels of tamsulosin to men who have BPH and who have difficulty swallowing tablets and capsules.

About Veru Inc.
Veru Inc. (Veru) is a biopharmaceutical company focused on urology and oncology. The company is currently developing drug product candidates: Tamsulosin DRS, slow release granules, and Tamsulosin XR capsules for lower urinary tract symptoms of benign prostatic hyperplasia (BPH) (NDA planned 2018), Solifenacin DRG, slow release granules, for overactive bladder (urge incontinence, urgency and frequency of urination) (NDA planned 2019), Tadalafil/finasteride combination capsule for restricted urination because of an enlarged prostate (NDA planned 2019), VERU-944 (cis-clomiphene citrate) for hot flashes in men associated with prostate cancer hormone treatment (planned Phase 2 in 2018), and VERU-111 a novel oral anti-tubulin cancer therapy targeting alpha & beta tubulin for a variety of malignancies, including metastatic prostate, breast, endometrial and ovarian cancers (planned Phase 1/2 in 2018).

To help support these clinical development programs, the company markets and sells the PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation which is being co-promoted with Timm Medical Technologies, Inc. and the FC2 Female Condom® (now available by prescription in the US including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com) in the United States and through The Female Health Company Division in the Global Public Health Sector. The Female Health Company Division markets 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.verupharma.com, www.PREBOOST.com, www.fc2.us.com and www.fc2femalecondom.com. For corporate and investor-related information about the Company, please visit https://verupharma.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. Forward-looking statements in this release include statements relating to the regulatory pathway to secure FDA approval of the Company's drug candidates, the anticipated timeframe for clinical studies and FDA submissions, future demand for FC2 and potential orders of FC2 by public sector customers. 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 because 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: risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; the expected timing of the clinical studies and regulatory approval of products under development; the outcome of the clinical trials and drug studies and that such outcomes will support marketing approval and commercialization; risks relating to the ability of the Company to obtain sufficient financing or raising capital on acceptable terms when needed to fund development and Company operations; product demand and market acceptance; competition in the Company's markets and the risk of new or existing competitors with greater resources and capabilities and new competitive product introductions; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays from the extensive governmental regulation, effects of healthcare insurance and regulation, including reductions in reimbursement and coverage. Some of the Company's products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents covering the products and processes and in successfully enforcing them against third parties; expectations regarding patent coverages; the possibility of infringing a third party’s patents or other intellectual property rights; 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 or substantial delayed payments; 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; penalties and/or debarment for failure to satisfy tender awards;  the Company's reliance on its international partners and on the level of spending 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 and interruptions; labor unrest or strikes, risks related to the costs and other effects of litigation, including product liability claims; 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 Company’s Annual Report on Form 10-K for the year ended September 30, 2017. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors.

Contact:
Kevin Gilbert
786-322-2213

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