FLEMINGTON, N.J.--(Business Wire)--
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.
FORWARD-LOOKING STATEMENTS:
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.
NovaDel Pharma Inc.
David H. Bergstrom, Ph.D., 908-782-3431 ext. 2150
Senior Vice President and Chief Operating Officer
dbergstrom@novadel.com
Copyright Business Wire 2009
