FDA Requests Additional Animal Data for VASOMAX; FDA Upgrades VASOMAX IND Status to Partial Clinical Hold.Business Editors/Health & Medical Writers THE WOODLANDS, Texas--(BUSINESS WIRE)--May 16, 2000 Zonagen, Inc. (Nasdaq:ZONA) (PCX (1) A bitmapped graphics file format that handles monochrome, 2-bit, 4-bit, 8-bit and 24-bit color and uses RLE to achieve compression ratios of approximately 1.1:1 to 1.5:1. Images with large blocks of solid colors compress best under the RLE method. See PC Paintbrush. :ZNG ZNG Zbor Nacionalne Garde (Croatian National Guard) ) announced today that the Company has been notified by the U.S. Food and Drug Administration (the "FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") that an additional animal study will be required before the FDA will consider the approval of VASOMAX(R). The FDA recommended that the Company conduct another two year rodent study due to concerns about the previously reported brown fat proliferations observed in the course of the earlier two year rat study in which phentolamine mesylate phentolamine mesylate, (fentol´  mēn´ mes´ilāt´),n brand name: Regitine; drug class: , the active ingredient in VASOMAX(R), was administered on a daily basis. The drug approval process allows sponsors the right to appeal the FDA's decision. Zonagen intends to exercise its right of appeal. The FDA also informed Zonagen that the status of the VASOMAX(R) IND has been upgraded to a partial clinical hold. Additional human studies of VASOMAX(R) for the treatment of male erectile dysfunction Erectile Dysfunction Definition Erectile dysfunction (ED), formerly known as impotence, is the inability to achieve or maintain an erection long enough to engage in sexual intercourse. may be conducted in the U.S., but must be limited to a duration of no more than three months and the total number of doses may not exceed three per week. A copy of this press release may be obtained via facsimile by dialing 888/329-0920 or via the Internet by accessing www.zonagen.com. Zonagen, Inc. is engaged in the development of pharmaceutical products for the reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus , including sexual dysfunction, vaccine adjuvants, products for fertility and female health as well as urological applications, specifically prostate cancer. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to the uncertainties related to the Company's early stage of development, clinical trial results and FDA approval in the U.S. and approval of regulatory authorities in other jurisdictions, substantial dependence on one product, future capital needs and uncertainty of additional funding, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , governmental regulation, limited sales and marketing experience and dependence on collaborators, competition and technology change and availability of insurance, and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1999, as filed with the Securities and Exchange Commission. |
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