2023-04-18 10:43:23 ET
Avenue Therapeutics ( NASDAQ: ATXI ) was trading around +4% on Tuesday after reporting progress in its efforts to secure approval for a Phase 3 clinical trial of its intravenous Tramadol.
The drug developer noted that the FDA was largely in agreement with its proposed study protocol that would assess the risk related to opioid stacking on IV Tramadol compared to IV morphine.
Avenue presented a study design for a single safety clinical trial of its candidate for treating post-operative pain in August 2022. It said that the trial design could address concerns regarding risks related to opioid stacking.
At the time the FDA said the proposed study design appeared reasonable and agreed on various design aspects. Avenue subsequently incorporated the agency's suggestions from the meeting.
The latest Type C meeting found the FDA and Avenue in agreement with most of the proposed protocol items. Both parties are in active discussion about remaining open items.
Avenue CEO Alexandra MacLean noted: "Our meeting with the FDA was very productive and led to agreement on many of the outstanding items regarding the proposed study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol relative to an approved opioid analgesic. We are finalizing the protocol based on the FDA’s feedback and look forward to the continued collaborative discussions with the FDA with the goal of partnering or initiating a Phase 3 safety study this year."
She added: "We expect that a positive study outcome could result in the approval of IV Tramadol. Additionally, we plan to provide updates on our other two programs later this year including the AJ201 clinical trial to treat spinal and bulbar muscular atrophy and the continued development of BAER-101 for epilepsy and acute anxiety."
For further details see:
Avenue Therapeutics makes progress in securing approval for Tramadol trial