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NovaDel's Nitroglycerin Lingual Spray Achieves Important Safety and Efficacy
Milestones In Randomized, Double-Blind Study
FLEMINGTON, N.J., Oct. 27 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc.
(BULLETIN BOARD: NVDL) announced the results of a clinical study of its
nitroglycerin lingual spray.
In a randomized, double blind study of 30 patients whose average age was 66.5,
three doses of the nitroglycerin spray (0.2, 0.4 and 0.8 mgs), was well
tolerated and produced positive changes in hemodynamic endpoints at rest, and in
the time until the development of exercise-induced angina.
The study showed highly statistically significant and clinically meaningful
dose-dependant increases vs. placebo in the amount of treadmill exercise time
needed to provoke the first onset of angina and to develop moderate angina.
The lingual nitroglycerin also extended the time to 1mm ST segment depression,
consistent with the anti-ischemic mechanism underlying its beneficial effect on
angina.
The ability of subjects to exercise to a higher rate-pressure product provides
substantial evidence of the effectiveness of the lingually delivered
nitroglycerin, the company said.
At rest, lingual spray nitroglycerin produced statistically significant
increases in heart rate and decreases in systolic blood pressure compared to
placebo.
These findings will be presented this week at the Annual Meeting of the American
Academy of Pharmaceutical Scientists, which takes place from October 27-29 in
Salt Lake City.
Nitroglycerin is the drug of choice for the acute relief of attacks of angina
pectoris because of its rapid onset of action. The currently marketed
sublingual and buccal tablets achieve maximal blood levels in 6-8 minutes, but a
spray formulation may be preferable because it eliminates the time required for
tablet dissolution.
NovaDel's spray is expelled forcibly via a propellant, unlike a pump spray
(which requires air to be introduced into the container on each actuation), thus
eliminating the potential for hydrolysis of the active product. This is likely
to offer a more reliably stable and more potent product over time.
The company recently filed US patents covering lingual spray versions of
Imitrex(R) (sumatriptan) and Zofran(R) (ondansetron), both marketed in the US by
GlaxoSmithKline, Ambien(R) (zolpidem), marketed in the US by Sanofi and Xanax(R)
(alprazolam), sold by Pfizer and several generic producers.
About NovaDel Pharma Inc.
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 (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 ability to develop products (independently and through
collaborative arrangements), and the ability to commercialize and obtain
approval for products under development. 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 203 222-7399
908 782-3431 x 2160 212 926-1733
NovaDel Pharma Inc.
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development, NovaDel
Pharma Inc., +1-908-782-3431, ext. 2160; Thomas Redington, +1-203-222-7399,
+1-212-926-1733, , for NovaDel Pharma Inc.