To further explore the safety and tolerability of ARRY-797, Array is currently conducting a multiple ascending dose trial in healthy volunteers at doses up to 2.5-fold higher than those evaluated in the osteoarthritis pain trial. ARRY-797 has been well-tolerated in this trial to date, and greater QTc prolongations were observed at these higher dose levels. No subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia. These QTc observations warrant further evaluation.“These results, together with our earlier studies in acute pain, provide evidence that ARRY-797 delivers therapeutic utility in both acute and chronic pain settings,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “Given the scope of a development program in pain, Array will aggressively seek a partner to maximize the value of this drug.”
Array BioPharma’s ARRY-797 Meets Primary Endpoint In Clinical Proof Of Concept Trial In Osteoarthritis Patients Whose Pain Is Poorly Controlled By NSAIDs
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