HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ:
IPXL), today announced the presentation of results from its RYTARYTM
(IPX066) Phase III and open-label extension trials at the 65th
Annual Meeting of the American Academy of Neurology in San Diego, CA on
March 18, 2013. IPX066 is an investigational extended-release capsule
formulation of carbidopa-levodopa being developed for the symptomatic
treatment of adult patients with idiopathic Parkinson’s disease. The
IPX066 data was presented as part of a poster session, entitled
“Movement Disorders: Parkinson’s Disease Therapy.”
The presentation of IPX066 posters was as follows:
Date and Time (all posters):
March 18, 2013 from 2:00-6:30, with
authors in attendance from 5:30-6:30 PM (local time)
Presentation Title and Number:
Long-Term
Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in
Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract
/ Poster Number: 3706/ P01.065
Presentation Title and Number:
Long-Term
Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in
Patients with Early Parkinson’s Disease
Abstract / Poster Number:
3662/ P01.064
Presentation Title and Number:
Analysis
of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients
Abstract
/ Poster Number: 49/ P01.063
On January 21, 2013, Impax received a complete response letter which
indicated that the FDA could not approve the NDA for IPX066 at that
time. The complete response letter stated that satisfactory resolution
and verification of the deficiencies identified during the inspection of
the manufacturing facility in Hayward, California would be required
before the NDA for IPX066 may be approved. On March 4, 2013, the Company
announced the receipt of a Form 483 following an inspection by the FDA
of the Hayward facility. The Form 483 contained several observations
specific to IPX066 which the Company believes must be satisfactorily
resolved before the NDA for IPX066 may be approved.
Open-Label Extension Study in Advanced Parkinson’s
Disease (PD) Patients
Advanced PD patients with motor
fluctuations who completed either study B08-11, a Phase 2, randomized,
open-label, 2-period (1 week per period), crossover pharmacokinetic and
pharmacodynamic study of IPX066 vs. immediate-release carbidopa-levodopa
(IR CD-LD ) or Study B09-02, a randomized, double-blind,
active-controlled, parallel group, 13-week comparison of IPX066 vs. IR
CD-LD, were eligible for study B09-03, an open-label extension study
lasting 9 months.
Three hundred forty nine (349) of 395 eligible advanced PD patients
(88.4%) entered the open-label extension study and 313 completed. The
most commonly reported adverse events (AEs) during the open-label
extension trial were dyskinesia, fall, pain in extremity, hallucinations
and arthralgia. The most common AEs reported in the previous trials were
headache, nausea, dyskinesia, insomnia and dizziness.
Open-Label Extension Study in Early PD Patients
Early
PD patients who completed Study B08-05, a randomized, double-blind,
fixed dose study of IPX066 vs. placebo over 30 weeks, were eligible for
study B09-03, an open-label extension study lasting nine months. Two
hundred sixty eight (268) of 300 eligible early PD patients (89.3%)
entered into the extension study and 254 completed. During the
open-label extension, the most frequently reported AEs were nausea,
insomnia, hypertension and headache. There were 16 serious AEs each
reported by one (0.4%) patient. No new patterns of AEs were observed.
Analysis of IPX066 Dosing in Study B09-02
IPX066
dosing in advanced PD patients was evaluated using data from Study
B09-02.
IPX066 doses were individually titrated by study investigators according
to their clinical evaluation. During this clinical trial, the total
daily IPX066 levodopa dose was approximately double that of the levodopa
IR dose received. The extended levodopa plasma concentration provided PD
patients with higher levodopa exposures without higher overall levodopa
maximum concentration. During this clinical study, the median dosing
frequency was three times/day for IPX066 while the median dosing
frequency was five times/day for CD-LD IR.
About RYTARY (IPX066)
RYTARY is an investigational extended-release capsule formulation of
carbidopa-levodopa being developed for the symptomatic treatment of
adult patients with idiopathic Parkinson’s disease. It is not approved
or licensed anywhere in the world. Results from the phase III studies of
RYTARY, APEX-PD (early PD patients), ADVANCE-PD (advanced PD patients)
and ASCEND-PD (advanced PD patients) have previously been announced.
About the Impax GSK Collaboration
Impax Pharmaceuticals and GSK announced an agreement for the development
and commercialization of IPX066 in December 2010. Under the terms of the
agreement, GSK received an exclusive license to register and
commercialize IPX066 throughout the world except in the U.S. and Taiwan.
About Impax Pharmaceuticals
Impax Pharmaceuticals is the branded products division of Impax
Laboratories, Inc. Impax Pharmaceuticals is focused on targeting
significant unmet needs, with a primary focus on developing treatments
for central nervous system disorders. For more information, please visit
its Web site at: www.impaxpharma.com.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of central nervous
system disorder branded products. Impax markets its generic products
through its Global Pharmaceuticals division and markets its branded
products through the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such as
injectables, nasal sprays, inhalers, patches, creams and ointments.
Impax Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia, Pennsylvania
and Taiwan facilities. For more information, please visit the Company's
Web site at: www.impaxlabs.com.
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To the extent any statements made in this news release contain
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Source: Impax Laboratories, Inc.