FDA Suggests NRx Bipolar Program Be Enlarged For Chronic Treatment Of Suicidality

 

• NRx Pharmaceuticals Inc 
  NRXP+1.79%+ Free Alerts
   reported the minutes of a Type B meeting with the FDA's Division of Psychiatry Products held in January.
• The purpose of the meeting was to discuss the requirements for submitting a marketing application for NRX-101. 
• FDA noted in written correspondence that the Special Protocol Agreement (SPA), granted in April 2019, remains in effect. 
• Additionally, the FDA suggested broadening the addressable population of the indication (under the SPA or otherwise) to patients with Severe Bipolar Depression and Recent Acute Suicidality, regardless of how the initial stabilization was accomplished could represent a more straightforward development program. 
• This broader indication would enable the company to potentially demonstrate the use of NRX-101 to maintain stabilization from suicidality in patients stabilized either with ketamine or with other standard-of-care therapeutic approaches. 
• This broader indication is not expected to delay the acute care trial expected to be completed in 2023.
• The FDA further advised the company that as a chronic, or chronic-intermittent treatment, the safety database requirement under ICH guidelines for NRX-101 should be 1,500 patients, with at least 100 treated for one year. The company is evaluating the timing and cost of expanding clinical access to this larger population. 

https://www.benzinga.com/general/biotech/23/02/30877958/fda-suggests-nrx-pharmas-bipolar-program-to-be-enlarged-for-chronic-treatment-of-patients-with-su