Axsome Therapeutics receives FDA approval for SYMBRAVO for migraine treatment
- SYMBRAVO, a combination of meloxicam and rizatriptan, is approved for acute migraine treatment in adults.
- The approval is based on Phase 3 trials (MOMENTUM, INTERCEPT, MOVEMENT) showing rapid and sustained pain relief.
- SYMBRAVO demonstrated superior efficacy in reducing migraine pain and symptoms compared to placebo and rizatriptan.
- Commercial availability in the U.S. is expected in approximately four months.
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Vertex announces FDA approval of suzetrigine for acute pain
- The FDA has approved JOURNAVX (suzetrigine), a non-opioid NaV1.8 pain signal inhibitor, for adults with moderate-to-severe acute pain.
- JOURNAVX is the first new class of pain medicine approved in over 20 years, offering effective pain relief without addictive potential.
- Vertex has set the wholesale acquisition cost for JOURNAVX at $15.50 per 50mg pill in the U.S.
- Vertex is also conducting a Phase 3 trial for suzetrigine in diabetic peripheral neuropathy and plans to evaluate it for lumbosacral radiculopathy.
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MindMed announces first patient dosed in Panorama, the second pivotal phase 3 study of MM120 in generalized anxiety disorder
- MindMed has dosed the first patient in the Panorama study, a Phase 3 trial for MM120 ODT in generalized anxiety disorder (GAD).
- The study will enroll approximately 250 participants across the US and Europe, evaluating MM120 ODT against placebo.
- Panorama is a 52-week study with a 12-week double-blind period followed by a 40-week open-label extension.
- The trial builds on Phase 2b results, which showed significant improvements in anxiety symptoms with MM120 ODT.
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Ryoncil commercial launch update and product pipeline
- Mesoblast is preparing for the U.S. commercial launch of Ryoncil for pediatric SR-aGVHD this quarter.
- The company secured $160 million in financing to support the launch and expand clinical indications.
- Ryoncil is the first FDA-approved MSC therapy for any indication, targeting a market with over $1 billion potential.
- Upcoming milestones include the launch of Ryoncil, Revascor FDA meeting, and Rexlemestrocel-L Phase 3 completion.
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