NovaDel's Nitroglycerin Lingual Spray Achieves Important Safety and Efficacy Milestones In Randomized, Double-Blind Study
2003年10月28日 - 3:06AM
PRニュース・ワイアー (英語)
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.
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