D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …

D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …
D-Pharm Ltd (DPRM: TASE) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA agreement letter indicates that “the design and planned analysis of the study adequately address the objectives …

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QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule Study For MoxDuo(R)IR In Patients With Post-Surgical …

QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule Study For MoxDuo(R)IR In Patients With Post-Surgical …
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced the successful completion of the first of two pivotal Phase 3 studies for MoxDuo®IR, an immediate-release Dual-Opioid™ pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study — comparing the efficacy and country profiles of MoxDuo®IR against component doses of morphine and oxycodone alone — demonstrated …

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