Attached files
file | filename |
---|---|
8-K - 8-K - AVANIR PHARMACEUTICALS, INC. | a57681e8vk.htm |
EXHIBIT 99.1
AVANIR PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF NUEDEXTA
*NUEDEXTA IS FIRST AND ONLY FDA-APPROVED TREATMENT FOR PSEUDOBULBAR AFFECT*
*AVANIR TO HOST CONFERENCE CALL ON NOVEMBER 1, 2010 AT 8:15 AM EASTERN TIME*
ALISO VIEJO, Calif., October 29, 2010 AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today
announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan
hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a
variety of otherwise unrelated neurological conditions, and is characterized by involuntary,
sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of
proportion or incongruent to the patients underlying emotional state.
The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an
under-recognized and debilitating neurologic condition, said Keith Katkin, president and chief
executive officer of Avanir. The approval of NUEDEXTA also marks AVANIRs transition toward
becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved
treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first
quarter of 2011.
This FDA approval represents a significant step forward for people who live with the debilitating
effects of PBA, said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy
Research at the National MS Society. For people who experience unexplained bouts of inappropriate
laughing or crying, this new therapy has the potential to substantially help both them and their
families.
Todays approval of NUEDEXTA is a testament to the conviction of the patients and researchers who
participated in our studies and represents over 10 years of research and development by our
dedicated employees, said Randall Kaye, MD, Chief Medical Officer, AVANIR Pharmaceuticals. We are
very pleased to bring the first proven treatment option to the many patients in the U.S. living
with PBA. I would like to thank FDA for working closely with us to make NUEDEXTA available.
PBA is a disabling neurologic condition commonly found in patients with underlying neurologic
diseases or injuries. These patients frequently experience embarrassment due to their unpredictable
emotional outbursts, leading to disruption of their interpersonal relationships and social
isolation, said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related
Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies
evaluating NUEDEXTA. As a physician who has cared for many patients with PBA, I am pleased that
there is now a safe and effective treatment option for PBA that may help these patients regain more
control over their daily lives and live with dignity.
4
NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain,
although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is
unknown. Studies to support the effectiveness of NUEDEXTA were performed in patients with
amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be
safe and effective in other types of emotional lability that can commonly occur, for example, in
Alzheimers disease and other dementias.
The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA
arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability
Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline
for the NUEDEXTA arm compared to placebo.
Conference Call
AVANIR will hold a conference call and audio webcast on November 1, 2010 at 8:15 a.m. Eastern time.
To participate in the conference call, please dial 877-558-3407 (domestic) or 706-679-1941
(international) and reference the access code 22130601. A live audio webcast of the conference call
will be available by visiting AVANIRs website at www.avanir.com. To listen to the live
presentation, please go to AVANIRs website prior to the start of the presentation to register,
download and install the necessary software. An archive of the conference call will be available on
the Companys website for 30 days.
About NUEDEXTA
NUEDEXTA is the first and only FDA-approved treatment for pseudobulbar affect (PBA). NUEDEXTA is
an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20
mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a
metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1
and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic
effects in patients with PBA is unknown.
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a
variety of otherwise unrelated neurological conditions, and is characterized by involuntary,
sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of
proportion or incongruent to the patients underlying emotional state. Studies to support the
effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and
multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of
emotional lability that can commonly occur, for example, in Alzheimers disease and other
dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in
the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic
Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score
from baseline for the NUEDEXTA arm compared to placebo.
NUEDEXTA Important Safety Information
NUEDEXTA can interact with other medications causing significant changes in blood levels of those
medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both
5
prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not
be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is
contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have
taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known
hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is
contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history
suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at
risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of
QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval
should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough,
vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver
enzymes, and flatulence.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken,
particularly for patients with motor impairment affecting gait or a history of falls.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules
in a 24-hour period, make sure that there is an approximate 12-hour interval between doses, and not
take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information
about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.
About PBA
Patients suffering from existing neurological disease or brain injury may also suffer the added
burden of pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated
neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of
laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the
patients underlying emotional state. PBA outbursts result from a short circuit in the brain
caused by another neurologic conditionsuch as multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the
lives of patients, caregivers and loved ones. For more information about PBA, please visit
www.PBAinfo.org.
About AVANIR Pharmaceuticals, Inc.
AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative
medicines to patients with central nervous system disorders of high unmet medical need. As part of
our commitment, we have extensively invested in our pipeline and are dedicated to advancing
medicines that can substantially improve the lives of patients and their loved ones. For more
information about AVANIR, please visit www.avanir.com.
6
About Forward-Looking Statements
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, goal, expect, project, or similar statements, may be 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. These statements
include, but are not limited to, AVANIRs ability to successfully market and sell NUEDEXTA in the
United States, the safety and efficacy of NUEDEXTA, and the anticipated timing and success of the
commercial launch of NUEDEXTA. Risks that could cause actual results to differ include the
occurrence of adverse safety events with NUEDEXTA, our limited capital resources, our dependence on
third parties for manufacturing and distribution of NUEDEXTA, that we may not adequately build or
maintain the necessary sales, marketing, supply chain management and reimbursement capabilities on
our own or enter into arrangements with third parties to perform these functions in a timely manner
or on acceptable terms, and other risks that are described in further detail in our most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to time in
other publicly available information regarding the Company. Copies of this information are
available from us upon request. We disclaim any intent to update these forward-looking statements.
Avanir Investor Contacts
Eric Benevich
Brenna Mullen
ir@avanir.com
949-389-6700
Brenna Mullen
ir@avanir.com
949-389-6700
Media Contact
Amanda Sellers, Spectrum Communications
202-955-6222
202-955-6222
# # #
7