NovaDel Pharma Initiates Human Study of Lingual Spray Version of
World's Leading Sleep Agent
Zolpidem is Company's Fourth Product Candidate To Enter Human Testing This Year
FLEMINGTON, N.J., Dec. 7 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. (AMEX:NVD) said it initiated a pilot pharmacokinetic feasibility study in
humans of a lingual spray formulation of zolpidem, the world's biggest selling
sleep-inducing agent, marketed in the U.S. as Ambien(R) by Sanofi-Aventis.
The new formulation utilizes NovaDel's patented lingual spray drug delivery
technology which is designed to achieve more rapid onset of therapeutic
activity. For users seeking quicker onset of sleep, this is considered a
desired benefit.
The pilot study will test the drug in a range of doses in humans to document
the profile of blood levels achieved using NovaDel's proprietary formulation of
zolpidem.
Based on successful results, NovaDel would file an Investigational New Drug
application to commence an abbreviated clinical development program designed to
support a 505(b)(2) submission, a form of New Drug Application (NDA) that
relies on data in previously approved NDAs and published literature.
Earlier this year the company filed its first 505(b)(2) NDA, seeking approval
for lingual spray nitroglycerin.
A pilot PK study of lingual spray alprazolam (Xanax(R)) is currently underway.
A pilot PK study of lingual spray sumatriptan (Imitrex(R)) was completed
earlier this year. Following submission of an IND later this month by
Manhattan Pharmaceuticals (NovaDel's licensee), lingual spray propofol will be
poised to begin full clinical development, and lingual spray nitroglycerin
(partnered to Par Pharmaceuticals) has been submitted to the FDA for marketing
approval.
NovaDel's lingual spray technology is designed to provide rapid therapeutic
blood levels by allowing drugs to enter the blood stream directly through the
mucosa lining the mouth. This route of delivery avoids the GI tract and
first-pass liver effects.
Patients self-administer the products just as they would a breath freshener.
NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the
development of novel drug delivery systems for prescription and over-the-
counter drugs. The company's proprietary lingual spray technology delivery
system offers the patient the potential for (i) fast onset of action; (ii)
improved drug safety by reducing the required drug dosage and reducing side
effects; (iii) improved patient convenience and compliance; and (iv) enhanced
dosage reliability. The company plans to develop such products independently
and through collaborative arrangements with major pharmaceutical and biotech
companies.
Except for historical information contained herein, this document contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve known and unknown risks
and uncertainties that may cause the Company's actual results or outcomes to be
materially different from those anticipated and discussed herein including, but
not limited to, the successful completion of its pilot pharmacokinetic
feasibility studies, the ability to develop products (independently and through
collaborative arrangements), the ability to commercialize and obtain FDA and
other regulatory approvals for products under development and the acceptance in
the marketplace for lingual spray products.. Further, the Company operates in
industries where securities may be volatile and may be influenced by regulatory
and other factors beyond the Company's control. Important factors that the
Company believes might cause such differences are discussed in the risk factors
detailed in the Company's most recent Annual Report and Registration
Statements, filed with the Securities and Exchange Commission. In assessing
forward-looking statements contained herein, if any, the reader is urged to
carefully read all cautionary statements contained in such filings.
Contact:
Barry C. Cohen
VP Business & New Product Development
908 782-3431 x2160
NovaDel Pharma Inc.
Thomas Redington
203 222-7399
212 926-1733
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of NovaDel Pharma Inc., +1-908-782-3431, x2160; or Thomas Redington, +1-203-222-7399, +1-212-926-1733,
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