In light of a then-pending NDA for Inspirion Delivery Sciences, LLC’s (“Inspirion’s”) ROXYBOND (oxycodone HCl) Tablets, 5 mg, 15 mg, and 30 mg (NDA 209777) for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, the CDER Exclusivity Board once again earlier this year had to assess the scope of 3-year exclusivity – in this case for XTAMPZA ER – and whether that exclusivity served as an obstacle to the approval of ROXYBOND. FDA subsequently granted Collegium a period of 3-year exclusivity for XTAMPZA ER that expires on Apand that is coded in the Orange Book as “NP” (for “New Product” exclusivity).
#XTAMPZA ER TRIAL#
In support of it’s NDA for XTAMPZA ER, Collegium conducted a couple of its own clinical investigations: an efficacy trial and a human abuse liability study assessing deterrence of intranasal abuse (Study CP-OXYDET-21). In a MaMemorandum, the CDER Exclusivity Board explained the Agency’s decision to grant a period of 3-year exclusivity with respect to the Apapproval of NDA 022272/S014 (see our previous post here), as well as the scope of that exclusivity: “the scope of 3-year exclusivity in this instance is limited to the addition of information to the labeling regarding the reduction of abuse via the intranasal route.” That exclusivity was granted based on FDA’s Apapproval of NDA 022272/S014, and was coded in the Orange Book as “M-153” (which is defined as: “ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN”). XTAMPZA ER was approved just days after the expiration of a period of 3-year exclusivity applicable to OXYCONTIN. XTAMPZA ER was approved as a 505(b)(2) NDA, relying on FDA’s finding of safety and effectiveness for OXYCONTIN (oxycodone HCl) Controlled-release Tablets (NDA 022272). On April 26, 2016, FDA approved Collegium Pharmaceuticals, Inc.’s (“Collegium’s”) NDA 208090 for XTAMPZA ER (oxycodone) Extended-release Capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
But before we give up the answer, some background is on order. And as with other recent 3-year exclusivity issues, the answer has come up in the context of abuse-deterrent opioids (see our previous posts here, here, here, and here). Well, there’s a Hatch-Waxman version of that question: “How many approvals does it take to get to the center of 3-year exclusivity?” While the world has known for a couple of years the answer to the Tootsie Pop question, FDA only recently provided an answer to the Hatch-Waxman version of the question. Ox圜ontin® Xtampza ER abuse-deterrent extended-release oxycodone pain prescription drug misuse.Children of the 1970/80s can easily recall that famous “How many licks does it take to get to the center of a Tootsie Pop?” commercial. This second pharmacokinetic study demonstrated that Xtampza ER maintains its ER properties after crushing, unlike Ox圜ontin, which failed to retain its ER properties after crushing. Crushed Ox圜ontin exhibited a rapid increase in plasma oxycodone and was bioequivalent to crushed oxycodone IR. Blood samples were collected to assess oxycodone concentrations.Ĭrushed and intact Xtampza ER resulted in lower peak plasma concentrations compared with crushed oxycodone IR crushed and intact Xtampza ER were bioequivalent. Healthy subjects received five equivalent oxycodone doses: Xtampza ER (intact or crushed), Ox圜ontin ® (intact or crushed) or immediate-release (IR) oxycodone (crushed).
This was an open-label, randomized, active-controlled, five-treatment, five-period, naltrexone-blocked, cross-over study. To further characterize the pharmacokinetics of Xtampza ® ER.
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