DEA Proposes Placing of Tapentadol Into Schedule II

By John A. Gilbert and Larry K. Houck –

The Drug Enforcement Administration (“DEA”) has published a notice of proposed rulemaking to control Tapentadol as a schedule II substance under the Controlled Substances Act.  Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II, 74 Fed. Reg. 7,386  (Feb. 17, 2009).  The Food and Drug Administration (“FDA”) approved Tapentadol, a new molecular entity, for marketing as a prescription drug for moderate-to-severe acute pain on November 20, 2008.  The Assistant Secretary for Health of the Department of Health and Human Services sent a scientific and medical evaluation of the drug to DEA, with the recommendation that it be placed in schedule II.  DEA found that Tapentadol has a high potential for abuse, has accepted medical use in treatment in the U.S. and its abuse may lead to severe psychological or physical dependence.

 Tapentadol is a centrally-acting synthetic analgesic that activates opioid receptors in the brain, spinal cord and gastrointestinal tract, and also inhibits reuptake of norepinephrine.  See FDA News, FDA Approves New Drug to Alleviate Moderate to Severe Pain, Nov. 24, 2008.  Although Tapentadol is a new molecular entity with no reports of diversion, abuse or law enforcement encounters, it “shares substantial pharmacological effects and abuse potential with other schedule II opioid analgesics, e.g., morphine, oxycodone, and hydromorphone.”  74 Fed. Reg. 7,386.

 Control of Tapentadol will subject handlers to registration and inventory requirements.  Tapentadol’s placement into schedule II will require compliance with specific schedule II security, quota, recordkeeping, ARCOS reporting and order form requirements.  

 Tapentadol is manufactured by Janssen Ortho, LLC, in doses of 50, 75 and 100 mg oral tablets.

 DEA requires that written comments on the proposed scheduling be postmarked on or before March 19, 2009, and that electronic comments be sent on or before midnight, EST, on March 19, 2009.