Aquestive receives FDA CRL for the remedy of allergic reactions with Anaphylm
Aquestive Therapeutics has acquired a whole response letter (CRL) from the U.S. Meals and Drug Administration (FDA) relating to its new drug utility (NDA) for Anaphylm, a sublingual movie formulation of dibutepinephrine.
The remedy goals to deal with kind I allergic reactions, together with anaphylaxis, in sufferers weighing 30 kg or extra.
Uncover B2B advertising that delivers
Mix enterprise intelligence and editorial excellence to succeed in engaged professionals throughout 36 main media platforms.
Extra info
The CRL highlights deficiencies within the human components validation for Anaphylm, comparable to improper movie placement and problem opening the pouch, which the FDA has indicated might trigger security considerations throughout anaphylaxis.
Aquestive has up to date the packaging and directions to be used and can conduct a brand new human components validation examine with these updates. The corporate may also handle tolerability in its resubmission.
No considerations have been raised about comparability knowledge or chemistry, manufacturing and controls (CMC) within the CRL.
Nonetheless, resulting from modifications in human components necessities, the FDA has requested a single pharmacokinetic (PK) examine to evaluate any modifications in packaging or labeling. The company acknowledged that human components and PK research can happen concurrently.
Aquestive plans to request a Sort A gathering with the FDA to evaluate resubmission choices and expects to resubmit an NDA within the third quarter of 2026, upon completion of required investigations.
The corporate continues regulatory actions for Anaphylm in Europe, the UK and Canada. Constructive suggestions from European regulators implies that no further medical trials are at present required earlier than purposes might be submitted.
The unique NDA included 11 medical trials totaling practically 967 administrations to 411 members.
Daniel Barber, president and CEO of Aquestive Therapeutics, mentioned: “We’re inspired that the problems within the letter are restricted to human components and a supportive PK examine, as soon as the human components are addressed, and we have now famous a number of labeling feedback that can decide the ultimate label for Anaphylm, if accepted by the FDA.
“We stay assured within the effectiveness and security of Anaphylm and its potential as an easy-to-use, easy-to-carry, fast-acting epinephrine remedy. We look ahead to working with the FDA to acquire approval for Anaphylm.”
In August 2025, Aquestive entered right into a $75 million strategic financing settlement with RTW Investments to assist the potential launch of Anaphylm.
