[{"orgOrder":0,"company":"Corium","sponsor":"KemPharm","pharmaFlowCategory":"D","amount":"$5.0 million","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Eligible to Receive $5 Million Milestone Payment from Gurnet Point Capital After NDA Filing for Potential New ADHD Treatment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Corium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Novel Once-Daily Capsule AZSTARYS","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 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Find Clinical Drug Pipeline Developments & Deals by Corium International, Inc
ADLARITY (donepezil transdermal system) developed by Corium, is the first and only U.S. FDA approved once-weekly, donepezil transdermal system for patients with mild, moderate and severe dementia of the Alzheimer's type.
Under the terms of the agreement, Lotus will have exclusive rights to commercialize Adlarity (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in the applicable territory and will be responsible for the regulatory approval process.
Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients. CNS stimulants prescribed for treatment of ADHD have been associated with height and weight growth.
ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin. Donepezil is the most prescribed medication in a class of Alzheimer's drugs known as acetylcholinesterase inhibitors.
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.
AZSTARYS is the first and only medicine containing SDX, a prodrug of d-MPH, which provides for an extended duration of d-MPH release throughout the day. Once-daily AZSTARYS is available nationally in the U.S. in three SDX/immediate-release d-MPH dose strengths.
KemPharm is due to receive the fee, within 30 days following FDA approval of ADLARITY, pursuant to a master development services agreement entered into with Corium in July 2020, under which KemPharm provided development related to Corium’s resubmission of its NDA for ADLARITY.
The approval of ADLARITY (donepezil transdermal system) reinforces the value of Corium's innovative CORPLEX technology, our CNS expertise, and our mission to deliver solutions that transform care for the Alzheimer's community and others impacted by CNS diseases.
The ADLARITY transdermal patch is constructed to be worn for seven days with consistent adhesion, a delivery method that avoids the difficulties associated with daily delivery of an oral medication for patients with significant memory problems.
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