Aquavit Submits NDA for New Neurotoxin

March 27, 2022
Aquavit Submits NDA for New Neurotoxin image

Aquavit Pharmaceuticals, Inc. has submitted its IND for a new botulinum toxin (DTX-021) to the FDA for approval. The company also unveiled its development programs at the Annual meeting of the American Academy of Dermatology in Boston.

DTX-021, a botulinum toxin type A drug intended for the treatment of moderate to severe glabellar lines, is a highly purified and clinically tested injectable neuromodulator with a 900kDa protein complex derived from neurotoxins produced by Clostridium botulinum.

Aquavit says it will be initiating a long-term Phase-II clinical trial shortly after approval of the IND. With FDA approval, DTX-021 (to be marketed as Dermatox™) will enter the fast growing US $5.3 billion dollar market with a CAGR of 7.8%, reaching US $9 billion dollars by 2026. 

Aquavit is accelerating its clinical development program by introducing DTX-022 shortly after DTX-021. With final approval of DTX-022, it will be the world's first FDA approved pan-facial microinjection of neurotoxins. DTX-022 features a novel route of administration (RoA) of DTX-021 utilizing Aquavit's innovative microchannel delivery system, a patented "repeated motion" technology.

For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin.  Aquavit is currently evaluating all other potential therapeutic indications of botulinum toxins.

 "We are thrilled to present DTX-021 and DTX-022 programs at this year's AAD. With Aquavit's proven track record of developing and launching a global brand such as AQUAGOLD®, combined with our network of physicians and knowledge of botulinum toxins, we are poised to make a significant impact in the fast-growing multi-billion dollar neurotoxin market," says Sobin Chang, CEO of Aquavit. "We plan to introduce the most innovative botulinum toxin programs to uplift and modernize the treatment paradigm."

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