NovaDel Successfully Delivers Sumatriptan (Imitrex(R)) Via
Lingual Spray
Data Indicates Absorption Through Oral Mucosa Holds Promise of Faster-Acting
Migraine Remedy With NovaDel Technology
FLEMINGTON, N.J., Oct. 14 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. (AMEX:NVD) reported preliminary findings of an important pilot pharmacokinetic
study of its lingual spray version of sumatriptan, the active ingredient in
GlaxoSmithKline's market leading migraine remedy, Imitrex(R).
The findings showed that the mean time to reach maximal blood concentrations of
the active drug with a 15 mg lingual spray dose was approximately 20 minutes
shorter than with the 50 mg Imitrex(R) tablet, and that the total amount of
drug delivered during the first 30 minutes (as measured by AUC normalized for
dose) was approximately 40 percent higher, and well within the therapeutic
range of plasma concentrations.
Published literature indicates that earlier achievement of therapeutic blood
levels of sumatriptan is associated with greater efficacy, as well as with
faster relief of migraine symptoms.
The sumatriptan lingual spray had a favorable safety profile and was well
tolerated. None of the nine subjects dropped out of the study, which was
designed to evaluate the pharmacokinetic profile of NovaDel's proprietary
lingual spray sumatriptan in doses ranging from 2.5 mg to 30 mg, compared to
the currently available 50 mg oral tablets and 6 mg subcutaneous injection.
"To our knowledge, this is the first time sumatriptan has been successfully
delivered through the oral mucous membranes," said Gary A. Shangold, MD,
president and chief executive officer of NovaDel. "This adds additional
strength to our expanding portfolio of human data with lingual sprays in a
variety of drug categories, and further demonstrates the versatility of our
drug delivery platform," he added.
With more than $1.2 billion in annual sales, sumatriptan is the leading
migraine remedy. A lingual spray formulation could offer migraine sufferers
faster onset of pain relief and may be particularly useful for patients whose
nausea and vomiting during migraine attacks makes it difficult for them to take
oral sumatriptan tablets.
NovaDel said it plans to move its lingual spray sumatriptan forward into full
development, possibly with partner funding now or in the future. The next step
will be protocol development for clinical studies to meet the requirements of a
New Drug Application under 505(b)(2).
The study also provided potentially useful dose related data. Among other
findings it showed that when the lingual spray dose was increased to 30 mg and
the spray was localized under the tongue, mean plasma concentrations of the
drug increased appreciably during the first nine minutes post dosing compared
to the 50 mg tablet, achieving 162 percent higher concentrations at the three
minute mark, 122 percent higher at six minutes and 45 percent higher
concentrations at the nine minute mark, as the tablet drug dissolved and became
more available for absorption.
For a majority of doses, NovaDel's patented lingual spray technology delivered
sumatriptan in the expected therapeutic range of plasma concentrations.
The study demonstrated a clear dose-concentration relationship for major
pharmacokinetic parameters over the evaluated range of lingual spray doses. Dose-normalized peak plasma concentrations (Cmax) and areas-under-the-curve
(AUC) reached with certain doses not only exceeded the 50 mg Imitrex tablet in
this study, but also appeared to be greater than those for the commercially
available 20 mg Imitrex nasal spray, although this formulation was not included
in the study.
About Migraines Migraines affect approximately 28 million people in the United States alone and
one in every four U.S. households has a migraine sufferer. Migraine attacks can
last from 4 hours to 72 hours and are typically characterized by sharp
pulsating pain on one side of the head, nausea, and extreme sensitivity to
light and sound. While the precise mechanism of migraine is unknown,
researchers believe migraine attacks are caused by acute inflammation
surrounding selected vessels in the head. The average migraine sufferer
experiences the first attack during the early teen years, and the attacks
generally continue throughout adulthood.
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 the potential for (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. To find out more about NovaDel Pharma Inc. (AMEX:NVD), visit our
website at http://www.novadel.com/ .
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 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 lingual spray products. 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
VP Business & New Product Development
NovaDel Pharma Inc. 908.782.3431 x 2160 Thomas Redington
Redington, Inc. 203.222.7399
212.926.1733
Web sites: http://www.novadel.com DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development, NovaDel Pharma Inc., +1-908-782-3431 x 2160; or Thomas Redington, of Redington, Inc.
for NovaDel Pharma Inc., +1-203-222-7399, or +1-212-926-1733,
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