AVNR News AVANIR Announces Last Patient Enrolled in Neuropathic Pain Phase III Trial with Zenvia
SAN DIEGO--(BUSINESS WIRE)--AVANIR Pharmaceuticals (NASDAQ:AVNR) announced today that the Company
has enrolled the targeted number of patients needed to assess the
efficacy endpoint in its ongoing Zenvia Phase III painful diabetic
neuropathy trial.
The protocol for the Phase III study was reviewed by the U.S. Food and
Drug Administration (FDA) through a special protocol assessment (SPA)
process. An SPA is an agreement between the FDA and the sponsor of a
clinical trial documenting that if the study endpoints are met, the
results should be acceptable to support a New Drug Application (NDA).
Assuming positive outcomes, AVANIR currently expects to use the data
from this study as one of the pivotal Phase III clinical trials required
before it would be able to submit an NDA for this indication.
“In the statistical plan, a total of 364
patients would be required to obtain 90% power with a 30% allowance for
drop out,” said Randall Kaye M.D., Vice
President of Clinical and Medical Affairs for AVANIR “We
have determined that it is unnecessary to enroll additional patients and
now consider the trial fully enrolled with approximately 380 patients.
The data from the trial is currently anticipated in mid-2007.”
Painful diabetic neuropathy may affect more than 50% of patients with
diabetes as their disease progresses, according to the American Diabetes
Association. The damaged nerves can alter the sensitivity of pain
centers in the spinal cord and consequently intensify pain transmission
within the central nervous system. Symptoms of painful diabetic
neuropathy may include numbness or insensitivity to pain or temperature,
a tingling, burning, or prickling sensation, sharp pains or cramps,
extreme sensitivity to touch, and loss of balance and coordination.
About AVANIR
AVANIR Pharmaceuticals is focused on developing, acquiring and
commercializing novel therapeutic products for the treatment of chronic
diseases. AVANIR’s products and product
candidates address therapeutic markets that include the central nervous
system, cardiovascular disorders, inflammation and infectious diseases.
AVANIR currently markets FazaClo®,
the only orally-disintegrating formulation of clozapine for the
management of severely ill schizophrenic patients who fail to respond
adequately to standard schizophrenic drug treatments. FazaClo is also
indicated for reducing the risk of suicidal behavior in patients with
schizophrenic or schizoaffective disorder. For full prescribing
information and important safety information regarding FazaClo, please
visit www.fazaclo.com. Zenvia™,
AVANIR's lead product candidate for the treatment of involuntary
emotional expression disorder (IEED), is the subject of an approvable
letter from the FDA and future development plans for this product
candidate are under consideration. The Company does not know at this
time what impact, if any, the ongoing discussions with the FDA for IEED
may have on the development of Zenvia for other indications.
Additionally, AVANIR has completed the patient recruitment in a Phase
III clinical trial with Zenvia as a potential treatment for patients
with painful diabetic neuropathy. AVANIR has active collaborations with
two international pharmaceutical companies: Novartis International
Pharmaceutical Ltd. for the treatment of inflammatory disease and
AstraZeneca for the treatment of cardiovascular disease. The Company's
first commercialized product, abreva®,
is marketed in North America by GlaxoSmithKline Consumer Healthcare and
is the leading over-the-counter product for the treatment of cold sores.
Further information about AVANIR can be found at www.avanir.com.
Forward Looking Statement
Statements in this press release that are not historical facts,
including statements that are preceded by, followed by, or that include
such words as "estimate", “intend”,
"anticipate", "believe", "plan", or "expect", or similar statements, are
forward-looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially from
the future results expressed or implied by such statements. There can be
no assurance that the Company will continue the clinical development of
Zenvia after its planned meeting with the FDA or that Zenvia will
receive FDA regulatory approval for any indication. There can also be no
assurance that the FDA will not require additional evidence of Zenvia’s
safety and/or efficacy, notwithstanding the existence of an SPA for the
Company’s neuropathic pain clinical trials.
If regulatory approval is received, there can be no assurance that
AVANIR will be able to market Zenvia successfully. Final review
decisions made by the FDA and other regulatory agencies concerning
clinical trial results are often unpredictable and outside the influence
and control of the Company. Risks and uncertainties also include the
risks set forth in AVANIR's most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q, in the Company’s
Current Report on Form 8-K filed with the SEC on November 3, 2006, and
from time-to-time in other publicly available information regarding the
Company. Copies of this information are available from AVANIR upon
request. AVANIR disclaims any intent to update these forward-looking
statements.
