NovaDel Receives Notice of Allowance for New U.S. Patent Covering its Oral Spray Drug Delivery Technology
November 05 2009 - 9:03AM
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.
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