FDA Clears Cingulate To File For Marketing Approval Of CTx-1301 For ADHD Treatment
Portfolio Pulse from Benzinga Newsdesk
The FDA has cleared Cingulate to file for marketing approval of CTx-1301, a treatment for ADHD. Phase 3 data collected so far is sufficient for a New Drug Application. CTx-1301 could benefit over 60% of ADHD patients currently using immediate-release booster doses. Cingulate is advancing discussions with commercialization partners and is ready to engage with payers for reimbursement and market access.
May 21, 2024 | 1:21 pm
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Cingulate has received FDA clearance to file for marketing approval of its ADHD treatment, CTx-1301. The Phase 3 data is sufficient for a New Drug Application, and the treatment could benefit over 60% of ADHD patients currently using immediate-release booster doses. The company is also advancing discussions with commercialization partners and preparing to engage with payers for reimbursement and market access.
The FDA clearance to file for marketing approval is a significant milestone for Cingulate, indicating regulatory progress and potential market entry. The Phase 3 data sufficiency and the potential benefit to a large patient population are positive indicators. Advancing discussions with commercialization partners and payers further supports a positive short-term outlook.
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