NovaDel Initiates Human Study of Lingual Spray Version of
Pfizer's Xanax(R), the Leading Anti-Anxiety Drug
Announcement Covers Third of Five Products Scheduled for Testing in Humans This
Year
FLEMMINGTON, N.J., Sept. 23 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. (AMEX:NVD) said it has commenced a pilot pharmacokinetic feasibility study in
humans of a lingual spray version of alprazolam, a widely prescribed anti-
anxiety medication marketed as Xanax(R) by Pfizer, Inc, and as a generic by
several producers.
The drug's new formulation utilizes NovaDel's patented lingual spray drug
delivery technology, designed to achieve more rapid onset of therapeutic
activity. This is considered a desired benefit for patients who seek quick
relief from periods of anxiety.
The study involves the administration of the test drug in a range of doses to
human subjects to document the profile of blood levels achieved using NovaDel's
proprietary formulation of alprazolam.
Based on successful results of the study, 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. The 505(b)(2) would be filed under the agency's PDUFA guidelines and generally
involves a 10-month review.
Earlier this year the company filed its first 505(b)(2) NDA, seeking approval
for lingual spray nitroglycerin.
The two additional drugs scheduled for human testing this year are lingual
spray versions of Zofran(R) (ondansetron), marketed in the US by
GlaxoSmithKline, and Ambien(R) (zolpidem) marketed in the US by Sanofi.
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 Thomas Redington
VP Business & New Product Development Redington, Inc. NovaDel Pharma Inc. 203.222.7399
908.782-3431 x 2160 212.926.1733
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of NovaDel Pharma Inc., +1-908-782-3431 ext. 2160; or Thomas Redington of Redington, Inc., +1-203-222-7399, or +1-212-926-1733, , for NovaDel Pharma Inc.
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