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NVDL GraniteShares ETF Trust GraniteShares

77.80
-2.78 (-3.45%)
Pre Market
Last Updated: 12:01:00
Delayed by 15 minutes
Name Symbol Market Type
GraniteShares ETF Trust GraniteShares NASDAQ:NVDL NASDAQ Exchange Traded Fund
  Price Change % Change Price Bid Price Offer Price High Price Low Price Open Price Traded Last Trade
  -2.78 -3.45% 77.80 77.80 77.88 1,182,791 12:01:00

NovaDel's Nitroglycerin Lingual Spray Achieves Important Safety and Efficacy Milestones In Randomized, Double-Blind Study

27/10/2003 6:06pm

PR Newswire (US)


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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.

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