Collegium Delays Launch of OxyContin Variation Xtampza
December 30, 2015
By Mark Terry, BioSpace.com Breaking News Staff
On Nov. 9, the U.S. Food and Drug Administration gave Xtampza ER (oxycodone) extended-release capsules tentative approval for Collegium’s New Drug Application (NDA). The FDA noted that Xtampza ER met all the required quality, safety and efficacy standards, but there was an automatic stay of up to 30 months because of patent litigation filed by Purdue back in March 2015.
Headquartered in Cranbury, N.J., Purdue Pharma L.P.’s lawsuit argues that Xtampza ER infringes three Orange Book patents that were recently found to be invalid by the U.S. District Court for the Southern District of New York. Those cases are being appealed.
As the Nov. 9 press release stated, “If Collegium receives a court order that the listed patents are invalid or not infringed, or if Collegium settles the Purdue litigation prior to the expiration of the 30-month period, the FDA can then provide final approval of Xtampza ER, at which point the product can be marketed.”
Xtampza is designed to be an abuse-deterrent opiate. Purdue Pharma, which markets OxyContin, also has several oxycodone abuse-deterrent products on the market, including OxyContin, Targiniq (oxycodone and naloxone extended-release tablets), and Hysingla ER (hydrocodone extended-release tablets). A competing product, Embeda (morphine sulfate and naltrexone extended-release capsules) is marketed by Pfizer, Inc. (PFE)
On Sept. 11, the FDA recommended against approving another related Purdue Pharma product, Avridi. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 23 to 1 against the approval. Avridi is to be taken every four to six hours on an empty stomach. Any food would decrease the drug’s effects, which, the panel said, would cause patients to take more of it, leading to potentially dangerous dosages. Most opioid medications can be taken regardless of food intake.
Extended-release versions of OxyContin are designed to make it more difficult to crush or snort the drugs. There had also been some controversy earlier when the FDA approved the use of OxyContin for children as young as 11 years of age. The FDA had specifically asked Purdue Pharma to study the drug for safety in children ages 11 to 16, because children have fewer pain medication options.
Collegium’s Xtampza is designed to prevent intravenous and intranasal abuse. It uses DETERx technology, made up of minuscule beads of oxycodone in a solution that is stored in a capsule.
The District Court of Massachusetts issued an order that puts off the court proceedings regarding the patent until Feb. 25, 2016. At that time, representatives from Purdue and Collegium are scheduled to discuss possible settlement of the litigation.
The initial three lawsuits were invalidated for obviousness by a court in the Southern District of New York by Purdue Pharma against Teva Pharmaceuticals USA, Inc. Purdue appealed the obviousness ruling to the Federal Circuit. Oral arguments were heard regarding this appeal on Nov. 3, 2015.
The number of players involved in these lawsuits is a little complicated. In April, a New York federal judge ruled that Amneal Pharmaceuticals LLC infringed Purdue Pharma L.P.’s patent with a generic version of OxyContin. But the judge found that Purdue’s claims were invalid as “obvious and indefinite.” Purdue accused Amneal of infringing its U.S. Patent No. 8,337,888.
Purdue sued Teva in July 2013 after the FDA indicated it wouldn’t accept generic versions of OxyContin over safety concerns. They also accused Teva of infringing on Patent No. 8,337,888, as well as Patent No. 8,309,060. Teva settled with Purdue in July 2014.