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NovaDel Pharma Inc. (NYSE AMEX: NVD), today announced that it received a
Notice of Allowance from the United States Patent and Trademark Office
(USPTO) for claims under U.S. Patent Application No. 10/671,715,
entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which
covers a method of treating insomnia by administering zolpidem to humans
utilizing NovaMist™ Oral Spray spray technology. Once issued, this
patent will expire in 2018.
As previously announced, NovaDel’s Zolpimist ™ (zolpidem
tartrate) 5 mg and 10 mg Oral Spray product is approved by the U.S. Food
and Drug Administration (FDA) for the short-term treatment of insomnia
characterized by difficulties with sleep initiation. Zolpimist is
NovaDel’s second product approved by the FDA that uses NovaDel’s
proprietary NovaMist oral spray technology. Zolpimist contains zolpidem
tartrate, the same active ingredient as Ambien®, the world’s
leading sedative hypnotic for the treatment of insomnia.
NovaDel maintains an extensive worldwide portfolio of intellectual
property rights for select compounds using its pioneering oral spray
delivery system. Upon issuance of the application, the Company will have
been granted nine patents in the U.S., three patents in Canada and 66
patents throughout Europe, including Austria, Belgium, Denmark, Finland,
France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg,
Monaco, Netherlands, Portugal, Spain, Sweden and Switzerland.
Additionally, NovaDel has over 80 patents pending around the globe.
Important Safety Information
Zolpimist is indicated for the short-term treatment of insomnia
characterized by difficulties with sleep initiation. Due to its rapid
onset of action, patients should take Zolpimist immediately before
bedtime and be prepared to get a full night's sleep (7-8 hours).
Patients should use extreme care in or avoid engaging in activities
requiring full alertness such as driving or operating hazardous
machinery the morning after taking any sleep medication. Do not take any
sleep medicine with alcohol. Complex behaviors such as somnambulism
(sleepwalking), including driving or eating while not fully awake, with
amnesia for the event, as well as cases of severe allergic reactions
have been reported in patients who have taken a sedative hypnotic.
Patients reporting such events should contact their physician
immediately, discontinue use and not be rechallenged. Prolonged usage of
a sedative hypnotic should be avoided without first consulting a
physician. Patients experiencing unusual changes in thinking or
behavior, or if sleep problems persist, should see their physician as
these may be indicative of another medical condition. Sedative hypnotics
are non-narcotic, however they do have some risk of dependency. The most
commonly observed side effects in controlled clinical trials were
headache, somnolence and dizziness. For full prescribing information,
including the FDA medication guide and patient instructions for use,
please visit www.novadel.com.
Ambien is a registered trademark of sanofi-aventis.
ABOUT NOVADEL PHARMA
NovaDel Pharma Inc. is a specialty pharmaceutical company developing
oral spray formulations for a broad range of marketed drugs. The
Company’s proprietary technology offers, in comparison to conventional
oral dosage forms, the potential for faster absorption of drugs into the
bloodstream leading to quicker onset of therapeutic effects and possibly
reduced first pass liver metabolism, which may result in lower doses.
Oral sprays eliminate the requirement for water or the need to swallow,
potentially improving patient convenience and adherence.
NovaDel’s oral spray technology is focused on addressing unmet medical
needs for a broad array of existing and future pharmaceutical products.
The Company’s most advanced oral spray candidates target angina, nausea,
insomnia, migraine headaches and disorders of the central nervous
system. NovaDel plans to develop these and other products independently
and through collaborative arrangements with pharmaceutical and
biotechnology companies. To find out more about NovaDel Pharma Inc.
(NYSE AMEX: NVD), visit our website at www.novadel.com.
Except for historical information contained herein, this document may
contain 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 oral spray products. The filing of an NDA with
the FDA is an important step in the approval process in the United
States. Acceptance for filing by the FDA does not mean that the NDA has
been or will be approved, nor does it represent an evaluation of the
adequacy of the data submitted. 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 on Form 10-K 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.