Wafermine (ketamine) / iX Biopharma - LARVOL DELTA

Use of ketamine wafer for pain management by volunteer emergency medical technicians in rural Western Australia. (PubMed, Emerg Med Australas) - "Sublingual ketamine wafer was administered by volunteer EMTs without any evidence of major adverse events in rural WA and deemed useful as an additional pain management option when long transport to hospital was needed. No other symptoms that may be associated with the use of ketamine were recorded."

Journal • Mood Disorders • Pain

iX Biopharma reverses from losses to net profit of $3.7 mil in 1HFY2022 from out-licensing of Wafermine (The Edge Markets) - "Revenue surged nearly 16 times to $13.2 million in the 1HFY2022 from $830,000 due to the income from the out-licensing of Wafermine to Seelos Therapeutics in November 2021....According to iX Biopharma, the partnership with Seelos Therapeutics could also generate additional development and sales milestone payments of up to US$239 million ($320.9 million) and sales royalties moving forward."

Commercial • Depression • Pain

"$SEEL iX Biopharma Signs Exclusive License Agreement For Wafermine And Other Sublingual Ketamine Wafer Products https://t.co/EwuBSBiZof" (@stock_titan)

Licensing / partnership • M&A

"We have had patients on 10-15 mg bd and one breakthrough as possible for various patients Wafermine- not trialled. Yes available" (@pritanand)

Clinical

iX Biopharma reports on outcome of wafermine end-of-phase 2 meeting with US FDA (PRNewswire) - "...iX Biopharma Ltd...is pleased to announce that it has successfully concluded an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Wafermine, a sublingual ketamine wafer for the treatment of acute moderate to severe pain....During the meeting, the Company and the FDA reached agreement on key aspects of the pivotal Phase 3 clinical trial program to support approval of Wafermine for the indication of acute moderate to severe pain."

FDA event

First sublingual ketamine drug for treatment of acute pain to be evaluated in End-of-Phase 2 meeting with FDA (PRNewswire) - P2, N=125; NCT03246971; Sponsor: iX Biopharma Ltd; "iX Biopharma Ltd...announced today that following the completion of its Phase 2 clinical study on Wafermine, a sublingual racemic ketamine wafer for the treatment of acute moderate to severe pain, the U.S. Food and Drug Administration (FDA) has scheduled the End-of-Phase 2 (EOP2) meeting with the Company in the third quarter of 2019."

FDA event • P2 data