Research Pit

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AXSM infos:

Anticipated Near-Term Clinical Milestones

• Clinical Trial Readouts:

•Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (late December 2017 to early January 2018)

•Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (late December 2017 to early January 2018)

•Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H 2018)



7 x Phase 3 Programs in Pipeline :

AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


AXS-02 CREATE-1 Complex regional pain syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status) ---No approved drug = high unmet need. 80,000 new cases per year in the U.S.


AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.


AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans