FLEMINGTON, N.J.--(Business Wire)--
NovaDel Pharma Inc. (NYSE AMEX: NVD) announced that an article titled "Rapid
Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute
Migraine" was published online on June 22, 2009 in the peer-reviewed journal
Headache: The Journal of Head and Face Pain. NovaDel conducted two clinical
trials evaluating sumatriptan administered via its oral spray drug delivery
technology. The objectives of the trials were: (1) To determine whether
sumatriptan can be absorbed across the oral mucosa, and, if so; then (2) to
describe its pharmacokinetics; and (3) to investigate whether there are
pharmacodynamic correlates of such pharmacokinetics in patients experiencing
migraine attacks.
The first clinical trial, in normal volunteers, compared the pharmacokinetic
performance of a lingual spray (LS) formulation of sumatriptan (2 dose sizes,
one of which in both the fed and fasted state) with a 50-mg sumatriptan tablet.
The second clinical trial, in a patient population enriched by documenting
suboptimal response to an initial 50-mg sumatriptan tablet, was a
multiple-attack, crossover, fixed dose-order, open-label comparison of
sumatriptan administered by LS (up to 3 different dose sizes) and a 100-mg
sumatriptan tablet.
The LS formulations resulted in double-peaked time-plasma concentration curves
that are consistent with absorption of sumatriptan across the oral mucosa. The
first "Tmax" was usually about 10-15 minutes. In the enriched patient
population, this corresponded with evidence of earlier efficacy for the LS in
comparison with a 50-mg tablet; the lower dose size for the former was
consistent with oral mucosal drug absorption, and evasion of first-pass
metabolism.
The initial pharmacokinetics of LS approximate to those of a subcutaneous
injection, albeit some fraction of these doses is also swallowed. These
pharmacokinetics correspond with earlier effectiveness of LS in comparison with
a 50-mg sumatriptan tablet, and at lower dose, in an enriched, relevant patient
population.
Results of this study were previously announced in a press release dated
September 4, 2008. The initial studies support further development of this
innovative formulation of sumatriptan and this new route of administration. Dr.
David Bergstrom, NovaDel`s COO, indicated "We are encouraged by the results of
these studies in providing a new potential treatment option for the very
debilitating condition of migraine attacks."
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. In
addition, our inability to maintain or enter into, and the risks resulting from
our dependence upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and distribution
of any of our products could materially impact the Company's actual results.
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.
For more detailed information regarding NovaDel`s 2008 financial results and its
product pipeline, please review the Company`s SEC filings on Form 10-Q at the
Investor Relations section of www.novadel.com.
NovaDel Pharma Inc.
Steven B. Ratoff, 908-782-3431 ext. 2650
Chairman and Interim Chief Executive Officer
sratoff@novadel.com
Copyright Business Wire 2009
