Increased bioavailability, faster absorption,
and less variability in plasma concentrations of inhaled
zolmitriptan CVT-427, compared to oral and nasal delivery in
healthy adults
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced
pharmacokinetic (PK) data from a Phase 1 study of CVT-427, an
inhaled formulation of zolmitriptan, resulting in increased
bioavailability and faster absorption compared to oral and nasal
administration of the same active ingredient in healthy adults. The
data on CVT-427, an investigational agent under development for the
acute treatment of migraines, will be presented on June 10th, 2016,
at the 58th Annual Scientific Meeting of the American Headache
Society, in San Diego, CA.
“When surveyed, the majority of migraine sufferers said rapid
pain relief is one of the most important factors influencing their
medication preference,” said Rick Batycky, Ph.D., Acorda
Therapeutics' Chief Technology Officer. “We’re encouraged by the
findings of this PK study, which support advancing development of
CVT-427 for the acute treatment of migraine.”
This Phase 1, open-label, intra-patient, single ascending dose
trial enrolled 21 healthy adults; 17 completed all treatments. Each
subject first received successively, single doses of the
zolmitriptan reference formulations, a 5 mg oral tablet and a 5 mg
nasal spray. Subjects then received four individual pre-metered
doses of CVT-427 (0.825 mg (0.6 mg delivered to the lung), 1.65 mg
(1.2 mg), 3.0 mg (2.4 mg), and 6.0 mg (4.8 mg) zolmitriptan). There
was a one or two day washout period between each
administration.
The oral and nasal spray formulations had a median Tmax of 1.5
hours and 3.0 hours, respectively; all four dose levels of CVT-427
had a median Tmax of 0.17 hours.
The mean Cmax for the oral formulation was 8.7 ng/mL, and the
nasal spray formulation was 8.1 ng/mL. The mean Cmax values for
CVT-427 were 6.0 ng/mL (0.825 mg dose), 11.8 ng/mL (1.65 mg), 17.8
ng/mL (3.0 mg), and 35.0 ng/mL (6.0 mg).
The mean AUC0-24 (ng·hr/mL) values for the reference
formulations were 49.0 for the oral, and 50.8 for the nasal spray,
whereas the mean AUC0-24 values for CVT-427 were 14.7 (0.825 mg
dose), 27.3 (1.65 mg), 47.1 (3.0 mg), and 91.0 (6.0 mg).
Coefficient of variation for AUC0-24 with reference products ranged
from 37.6%-38.4% compared with 26.7%-29.9% for CVT-427, showing
less variability.
PK parameters (including bioavailability) of the reference
formulations observed in the trial matched published reports. The
study found that CVT-427 had better bioavailability than the
reference formulations with less variability in plasma
concentration.
There were no serious adverse events, dose limiting toxicities,
or study discontinuations due to adverse events (AEs) reported for
CVT-427. The most commonly reported treatment-emergent AEs for
CVT-427 (≥10%) were cough (0.825 mg – 11%, 1.65 mg – 11%, 3.0 mg –
22%, 6.0 mg – 18%), chest discomfort (0.825 mg – 11%), headache
(1.65 mg – 11%) and feeling hot (3.0 mg – 11%, 6.0 mg – 24%). Other
than cough, single dose CVT-427 tolerability was generally
consistent with the known safety profile of zolmitriptan.
“Tolerability and Pharmacokinetics of Zolmitriptan Administered
via CVT-427, a Novel Pulmonary Delivery System,” (Poster #PF72LB)
will be presented on Friday, June 10th from 1:15pm – 2:30pm Pacific
Time. Herbert R. Henney III, PharmD, Vice President, Clinical
Pharmacology for Acorda, will present the poster. This study was
supported by Acorda Therapeutics, Inc.
More detailed information on the meeting can be found on the
conference website:
http://www.americanheadachesociety.org/58th_annual_scientific_meeting/
About CVT-427
CVT-427 is an inhaled formulation of zolmitriptan that uses the
Company’s proprietary ARCUS® technology. Zolmitriptan belongs
to a class of drugs known as triptans, which are a leading therapy
for acute treatment of migraines. An estimated 36 million
people in the United States, and over 40 million people in Europe,
suffer from migraines.
About ARCUS® Technology
Acorda’s proprietary ARCUS technology platform is a dry-powder
pulmonary delivery system that has potential applications in
multiple disease areas. This platform allows consistent and
precise delivery of significantly larger doses of medication than
are possible with conventional pulmonary systems. The ARCUS inhaler
is breath-actuated, operated by the user simply breathing in.
The ARCUS technology has been used to successfully deliver more
than one million doses to patients in clinical trials of various
products. There are currently two clinical-stage programs using the
ARCUS technology: CVT-301 (Phase 3) is in development as a
treatment for symptoms of OFF periods in Parkinson’s disease;
CVT-427 (Phase 1) is in development for the acute treatment of
migraines. Acorda has an extensive patent portfolio relating to
CVT-301, CVT-427 and the ARCUS technology, which covers aspects of
the formulated drug product, the inhaler, the method of drug
delivery and manufacturing processes.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a
biotechnology company focused on developing therapies that restore
function and improve the lives of people with neurological
disorders.
Acorda has an industry leading pipeline of novel neurological
therapies addressing a range of disorders, including Parkinson’s
disease, post-stroke walking difficulties, migraine, and multiple
sclerosis. Acorda markets three FDA-approved therapies,
including AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
For more information, please visit the Company’s website
at: www.acorda.com.
Forward-Looking Statement
This press release includes forward-looking statements. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects
should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially, including: the ability to complete the Biotie
transaction on a timely basis; the ability to realize the benefits
anticipated from the Biotie and Civitas transactions, among other
reasons because acquired development programs are generally subject
to all the risks inherent in the drug development process and our
knowledge of the risks specifically relevant to acquired programs
generally improves over time; the ability to successfully integrate
Biotie’s operations and Civitas’ operations, respectively, into our
operations; we may need to raise additional funds to finance our
expanded operations and may not be able to do so on acceptable
terms; our ability to successfully market and sell
Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of
unfavorable results from future studies of Ampyra or from our other
research and development programs, including CVT-301 or any other
acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully
market CVT-301, any other products under development, or the
products that we will acquire when we complete the Biotie
transaction; the occurrence of adverse safety events with our
products; delays in obtaining or failure to obtain and maintain
regulatory approval of or to successfully market Fampyra outside of
the U.S. and our dependence on our collaborator Biogen in
connection therewith; competition; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property
licenses needed for the commercialization of our products; and
failure to comply with regulatory requirements could result in
adverse action by regulatory agencies.
These and other risks are described in greater detail in our
filings with the Securities and Exchange Commission. We may not
actually achieve the goals or plans described in our
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this presentation are made only as of the date hereof, and we
disclaim any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this presentation.
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version on businesswire.com: http://www.businesswire.com/news/home/20160609005119/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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