AVANIR PHARMACEUTICALS REQUESTS MEETING WITH THE FDA
1/14/99 12:32
SAN DIEGO, Jan. 14, /PRNewswire/ -- Avanir Pharmaceuticals (Nasdaq: AVNR),
a developer of novel therapeutic products for the treatment of chronic
diseases, today filed a formal request for a meeting with the Federal Food and
Drug Administration (FDA). The purpose of the meeting will be to discuss the
additional data the FDA has requested before it can grant approval of Avanir's
New Drug Application (NDA) for docosanol, a topical treatment for oral-facial
herpes infections. Following earlier discussions with the FDA, the agency has
agreed to grant a meeting within 30 days after the request is received.
Gerald J. Yakatan, Ph.D., Avanir's president and chief executive officer
said, "We continue to believe that the data submitted in our NDA demonstrates
substantial evidence of effectiveness in the treatment of oral-facial herpes.
And we will work with the FDA to clarify the additional information they may
require."
"At this point, we are exploring several options to generate revenue in
1999, including an over-the-counter product that meets existing federal
regulatory requirements," concluded Dr. Yakatan.
Avanir Pharmaceuticals, based in San Diego, develops novel therapeutic
products for the treatment of chronic diseases. The company is also seeking
in-licensing agreements with other pharmaceutical companies for late-stage
products to complete its drug pipeline.
The information contained in this press release, including any forward
looking statements contained herein, should be reviewed in conjunction with
the Company's Annual Report on Form 10-K and other publicly available
information regarding the Company, copies of which are available from the
Company upon request. Such publicly available information sets forth many
risks and uncertainties related to the Company's business and such statements,
including risks and uncertainties related to drug development and clinical
trials. Final review decisions made by the FDA and other regulatory agencies
concerning clinical trial results are unpredictable and outside of the
influence and/or control of the Company.
SOURCE Avanir Pharmaceuticals
-0- 01/14/99
/CONTACT: Gregory Hanson, CFO of Avanir Pharmaceuticals, 619-410-2670; or
Bob Stone, home - 914-591-5534, or Ken DiPaola, both of The Dilenschneider
Group, 212-922-0900, for Avanir Pharmaceuticals/
(AVNR)
CO: Avanir Pharmaceuticals; Food and Drug Administration
ST: California
IN: MTC
SU: LEG
-0- Jan/14/1999 12:17 |
