FDA Approves an Extended-Release Formulation of Nucynta® (Tapentadol)

Medicare Set-Aside Blog on September 21, 2011
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Nucynta® (tapentadol) is a schedule II controlled substance that was approved by the FDA in November 2008  for the management of moderate to severe pain of both an acute and chronic nature. Nucynta® controls pain through the activation of mu opioid receptors, which are located throughout the central nervous system, peripheral nervous system and gastrointestinal tract. The recommended dose of Nucynta® for chronic pain is 50mg, 75mg or 100mg administered every 4 to 6 hours, with a maximum daily dose of 600mg. Nucynta® is an effective analgesic for many patients; however, the frequent dosing schedule is somewhat inconvenient and often presents difficulties from a medication compliance perspective. The majority of first-line pharmacologic agents used to treat chronic pain are oral extended-release formulations such as OxyContin ® and Avinza®, or transdermal preparations such as Duragesic®. These agents offer the convenience of less frequent dosing as compared to their immediate release counterparts, and are preferable from a medication compliance perspective.
On August 25, 2011, the FDA approved an extended-release formulation of Nucynta®. Nucynta® ER (tapentadol extended-release) is approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. As is the case with other long-acting or extended-release analgesics, Nucynta® ER is not appropriately utilized for acute pain. For patients currently taking Nucynta®, a dosing conversion to Nucynta ® ER is available. For opioid naïve patients, the recommended starting dose of Nucynta® ER is 50mg every 12 hours.
The availability of Nucynta® ER will impact the WCMSA for a claimant who is converted from Nucynta® to Nucynta® ER due to chronic pain, because current AWPs for the Nucynta® ER preparations are collectively higher than those for the Nucynta® products. To illustrate this effect, consider the following costs for two Nucynta® regimens and the corresponding Nucynta® ER regimens for a claimant with a life expectancy of 20 years:
Scenario #1:Nucynta® 75mg every 6 hours: $83,859.80
Conversion to Nucynta® ER 150mg every 12 hours: $99,878.40
Scenario #2: Nucynta ® 100mg every 6 hours – $111,666.20
Conversion to Nucynta® ER 200mg every 12 hours – $127,180.80
Although more costly than an equivalent dosing regimen of Nucynta®, Nucynta® ER will likely become the preferred agent among practitioners and patients alike. In the overwhelming majority of cases, the conversion to Nucynta® ER will serve to increase the pharmacy allocation for WCMSA claimants.