Adamas Pharmaceuticals Receives Orphan Drug Designation for ADS-5102 for the Treatment of Levodopa-Induced Dyskinesia Associa...
April 10 2015 - 8:30AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the
Food and Drug Administration (FDA) has granted orphan drug status
to ADS-5102 for the treatment of levodopa-induced dyskinesia
associated with Parkinson's disease. Adamas currently has multiple
Phase 3 studies underway evaluating ADS-5102 for this indication,
which currently has no FDA-approved treatment options.
"People with Parkinson's disease contend with the disability
associated with levodopa-induced dyskinesia multiple times a day as
the disease progresses and their motor symptoms fluctuate," said
Gregory T. Went, Ph.D., Chairman and CEO of Adamas
Pharmaceuticals. "Adamas is committed to bringing new
treatments to patients suffering with movement disorders related to
neurological disorders. With positive data from our Phase 2/3
study, a pivotal Phase 3 program well underway, and 10 issued US
patents, we are pleased with our ongoing momentum."
About Orphan Drugs
The Orphan Drug Act enables the FDA to grant special status to a
product that treats a rare disease or condition upon request of a
sponsor. For a drug to qualify for orphan drug designation,
the condition must meet certain criteria, including affecting fewer
than 200,000 people in the US. Once granted, orphan
designation qualifies the sponsor for various incentives including:
potential tax credits, a reduction in certain regulatory fees, and
the potential for seven years of market exclusivity for the drug
when it achieves FDA marketing approval.
About ADS-5102
Adamas' most advanced wholly owned product candidate is ADS-5102
(amantadine HCl), a high dose, extended-release version of
amantadine that is administered once daily at bedtime. Adamas
is initially developing ADS-5102 for the treatment of
levodopa-induced dyskinesia, or LID, in patients with Parkinson's
disease. LID is a complication that frequently occurs in
patients after long-term treatment with levodopa, the most widely
used drug for Parkinson's disease. There are no approved drugs
for the treatment of LID in the United States or Europe.
Parkinson's Disease and Levodopa-induced Dyskinesia
(LID)
Parkinson's disease is a chronic, progressive motor disorder
that causes a variety of symptoms, such as tremors, rigidity,
slowed movements and postural instability. The most commonly
prescribed treatments for Parkinson's disease are levodopa-based
therapies. In the body, levodopa is converted to dopamine to
replace the dopamine loss caused by the disease. Patients
initially receive relief from symptoms of Parkinson's disease for
much of the day. This period of relief is known as "ON"
time. As the effects of levodopa wear off, the symptoms of
Parkinson's disease return. This is known as "OFF"
time.
As Parkinson's disease progresses, most patients require
increasing doses of levodopa to achieve equivalent therapeutic
benefit. Patients may also experience symptoms of their
disease upon waking, prior to the first dose of levodopa taking
effect. Over time many patients will suffer from LID, a
condition characterized by involuntary movements without
purpose. LID can become severely disabling, rendering patients
unable to perform routine daily tasks. As Parkinson's disease
advances, the symptoms of LID worsen in frequency and
severity. Eventually the total time that a patient spends
either "OFF" or "ON" with LID can become a majority of his or her
day.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical
company driven to improve the lives of those affected by chronic
disorders of the central nervous system. The company achieves
this by modifying the pharmacokinetic profiles of approved drugs to
create novel therapeutics for use alone or in fixed-dose
combination products. Adamas is currently developing its lead
wholly-owned product candidate, ADS-5102, for a complication
associated with the treatment of Parkinson's disease known as
levodopa-induced dyskinesia, or LID, and is evaluating other
potential indications. The company's portfolio also includes
two approved products with Forest Laboratories Holdings Limited (a
subsidiary of Actavis plc), Namzaric™ and Namenda XR®. Forest
is responsible for marketing both products in the United States
under an exclusive license from Adamas. For more information,
please visit www.adamaspharma.com.
Namenda XR® is a registered trademark of Merz Pharma GmbH &
Co. KGaA.
Namzaric™ is a trademark of Actavis, Inc. or its affiliates.
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 including, but not limited to, statements regarding
bringing new treatments to patients suffering movement disorders.
Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements.
Words such as "committed" and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in forward-looking statements, including risks relating
to research and development activities of ADS-5102 and other
current and future products, challenges associated with clinical
trials including delays in enrollment, the failure to demonstrate
the safety and efficacy of ADS-5102 or other product candidates, as
well as risks relating to Adamas' business in general, see Adamas'
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 3, 2015. Investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Adamas undertakes
no obligation to update any forward-looking statement in this press
release.
CONTACT: Julie Wood
Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
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