JERSEY CITY, N.J., Aug. 29, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of positive results from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion?of liquid levodopa/carbidopa (LD/CD) – as part of the International Congress of Parkinson's Disease and Movement Disorder Society (MDS), being held in Copenhagen, Denmark, August 27-31. The study, which evaluated the efficacy, safety and tolerability of ND0612 in comparison to oral immediate-release (IR) LD/CD in people with Parkinson's disease (PD) experiencing motor fluctuations, met its primary endpoint and the first four secondary endpoints. Results, which follow positive topline data reported earlier this year, will be presented as both a poster and part of an Oral Platform Presentation at the meeting.
JAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s Disease
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced that the Canadian Intellectual Property Office (CIPO) issued a Notice of Allowance for a patent related to the use of AV-101 for reduction of dyskinesia (sudden uncontrolled movements) induced by the administration of levodopa (L-Dopa), the most commonly prescribed medication for treatment of Parkinson's disease (PD). AV-101 is the Company’s oral prodrug antagonist at the NMDAR (N-methyl-D-aspartate receptor) glycine site. The patent, once granted, will not expire until at least 2034. The U.S. Patent and Trademark Office (USPTO) granted a related U.S. patent for Vistagen’s AV-101 and similar patents have been granted or are pending in several additional major pharmaceutical markets.
New Delhi: AbbVie Inc said on Wednesday the U.S. Food and Drug Administration had declined to approve its Parkinson's disease therapy for adults and had requested more information on the device used to administer the treatment.
Enforcement Report - Week of March 8, 2023
PEARL RIVER, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that on December 31, 2022 it entered into a new long-term global supply agreement with Catalent for the manufacture of INBRIJA (levodopa inhalation powder) at its Center of Excellence for Spray Dried Dispersions in Boston where Catalent will continue to manufacture INBRIJA through 2030. The new agreement includes the scale-up to the larger pharma grade spray-dryer at a PSD-7 scale, which will provide expanded capacity for the long-term world-wide manufacturing requirements of INBRIJA.
Aurobindo's Generic Carbidopa, Levodopa Receives Approval in the U.S.
Rubicon's Generic Carbidopa, Levodopa Receives Approval in the U.S.
PEARL RIVER, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Esteve Pharmaceuticals GmbH has launched INBRIJA® 33 mg (levodopa inhalation powder, hard capsules) in Germany. INBRIJA is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor.
Levodopa, widely considered the standard of care for Parkinson’s disease, can reduce symptoms such as slow movement, stiffness, and tremors. But many patients taking the drug still experience “OFF time,” or periods where Parkinson’s symptoms present despite medication.