CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, announced positive topline results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration. The topline results were positive for the company’s lead candidate for OSA, AD109 (atomoxetine + aroxybutynin). The primary endpoint showed a statistically significant reduction in the Apnea-Hypopnea Index (AHI, the standard measure of OSA severity and nighttime breathing) for both doses studied (p<0.001 vs. placebo). Results from the MARIPOSA trial also demonstrated that AD109 improved daytime symptoms caused by OSA and was safe and well-tolerated. Results from this study support dose and endpoint selection for Apnimed’s Phase 3 studies of AD109, anticipated to start in the first half of 2023, following discussions with the U.S. Food and Drug Administration (FDA).
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, including its lead candidate AD109, today announced that company management will participate in the 2nd Annual Needham Biotech Private Company Virtual 1x1 Forum taking place October 18-19, 2022. Meeting schedules will be accessible to registered conference attendees.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced that data from a proof-of-concept study exploring two potential oral therapeutic candidates for the treatment of patients with OSA, AD504 (atomoxetine + trazodone) and AD182, will be featured in an oral presentation at SLEEP 2022 in Charlotte, NC, on Monday, June 6. SLEEP 2022 is the 36th annual meeting of the Associated Professional Sleep Societies (APSS), a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
NAPERVILLE, Ill., Nov. 17, 2021 (GLOBE NEWSWIRE) -- OWP nPharmaceuticals, Inc. is a privately held, commercial-stage neurosciencenspecialty pharmaceutical company, dedicated to developing and ncommercializing novel oral liquid formulations. OWP announced today thatnit has received IND authorization from the FDA for the first-ever oral nsuspension of atomoxetine hydrochloride. Offering an important delivery nalternative for a drug often used for attention deficit hyperactivity ndisorder (ADHD), this represents the fifth of several oral liquid nmedications in neuroscience that the company hopes to commercialize overnthe next several years via a 505(b)(2) application, in keeping with itsnpipeline of reformulated, approved therapeutics with no currently navailable liquid formulation.
Just a few months after a modest $25 million raise, little Apnimed has released some broadly positive data for its experimental sleep apnea drug.
NAPERVILLE, Ill., April 22, 2021 (GLOBE NEWSWIRE) -- OWP Pharmaceuticals, Inc. is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations. OWP announced today that it has submitted for U.S. patent protection, for the first-ever oral suspension of atomoxetine hydrochloride. Offering an important delivery alternative for a drug often used for attention deficit hyperactivity disorder (ADHD), this represents the fifth of several oral liquid medications in neuroscience that the company hopes to commercialize over the next several years via a 505(b)(2) application, in keeping with its pipeline of reformulated, approved therapeutics with no currently available liquid formulation.
Dr. Reddys Labs Generic Atomoxetine Hydrochloride Receives Approval In US
The company sued the Canadian government under the North American Free Trade Agreement for $500 million based on a classic trope: invent a fictional character to take the blame for one’s own failings. It lost the case, but confused everyone so much that the Supreme Court of Canada recently had to kill off the character.
Apotex, Teva Pharmaceutical Industries, Aurobindo and Glenmark made it past the FDA gatekeepers with their generics to a Lilly med that pulled in sales of $535 million in the U.S. and $854 million around the world last year.
SILVER SPRING, Md., May 30, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.nnApotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple strengths.