Nastech Files IND Application For Nasally Administered Buprenorphine Hcl
HAUPPAUGE, N.Y. -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) today announced the Company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to begin initial clinical evaluation of nasally delivered buprenorphine hydrochloride for the treatment of moderate to severe pain. If results are positive, the Company anticipates commencing Phase II/III clinical trials during the summer of 1998. Nastech has an exclusive license in the U.S. for the development and commercialization of nasally delivered buprenorphine.
Buprenorphine is a potent analgesic with unique properties. The compound may provide for less addiction liability than morphine and does not cause the same degree of respiratory depression, which is a common side effect of most opioid analgesics. This drug is currently available only as an injectable product. The Company believes its nasal delivery technology can be applied to develop a safe and effective formulation of buprenorphine that will broaden its therapeutic application. "As a result of its unique properties as a narcotic partial agonist, the Company has identified three therapeutic areas. These areas include post-operative surgical pain, first line oncology and migraine pain. It is estimated that over $500 million per year is spent in the U.S. on analgesics for pain management in these areas applicable to buprenorphine," commented Robert H. Rosen, Executive Vice President of Nastech.
"Being at the forefront of nasal drug delivery, Nastech is committed to the improvement of pain management through patient self-administration of optimized non-invasive analgesic therapy," commented Dr. Vincent D. Romeo, President and CEO of Nastech Pharmaceutical Company. "In comparison to other narcotic analgesics, buprenorphine has the advantages of lower dose, extended action, and wide margin of safety. A nasal dosage form will expand therapeutic application in patients whose physical condition or diseased state makes them intolerable to injectable therapy. It may also address inadequacy of pain management in children due to fear of injections."
Nastech is recognized worldwide as the foremost leader in nasal drug delivery. The company has R&D collaborations and commercial partnerships with several major pharmaceutical companies, including Bristol-Myers Squibb, Pfizer, Dupont-Merck, and Schwarz Pharma, among others, to develop products addressing sleeplessness, pain management, and other therapies.
In addition, the company has expanded its proprietary franchise in nasal technology to include 10 patents covering the nasal delivery of 65 compounds and an additional 3 patents pending.
Any statement contained herein that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involves risks and uncertainties. Information on the potential factors which could effect the Company's actual results of operations are included in its filing with the Security and Exchange Commission, including but not limited to its Annual Report on Form 10-K.
/CONTACT: Andrew Zinzi of Nastech, 516-273-0101; or Brad Miles, media,
Jonathan Fassberg, investors, both of BMC-Trout Group, 212-477-9007, for
Nastech/
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