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BioWorld - Saturday, January 24, 2026
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Home » On schedule: PDUFA date hit, DEA to deliberate Jazz sleep drug listing position
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On schedule: PDUFA date hit, DEA to deliberate Jazz sleep drug listing position

March 22, 2019
By Randy Osborne
Now that Dublin-based Jazz Pharmaceuticals plc has gained FDA marketing clearance for Sunosi (solriamfetol), investors are waiting to see how the DEA will schedule the compound, and J.P. Morgan analyst Jessica Fye said her "base case for DEA scheduling for Sunosi is [schedule] IV." The human abuse liability study compared the drug to phentermine and Sunosi "appeared less 'likable' than that schedule IV agent (note that [methylphenidate and d-amphetamine] are schedule II given their higher potential for abuse/dependence)," Fye wrote in a report.
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