Collegium gets tentative FDA approval for opioid painkiller

Collegium Pharmaceutical Inc said on Monday the U.S. Food and Drug Administration had tentatively approved its experimental opioid painkiller, with final approval depending on the outcome of a lawsuit filed by Purdue Pharma.

Purdue and Collegium have developed abuse-deterrent versions of the commonly prescribed and often-abused painkiller oxycontin, which contains highly addictive oxycodone.

Purdue Pharma has said that Collegium’s drug, Xtampza ER, infringes four of its patents.

Three of the patents were recently found to be invalid by a U.S. District Court, a decision that Purdue is appealing.

Collegium has been fighting a legal battle with Purdue over the patents for eight months in three states.

Xtampza ER is Collegium’s lead experimental drug. Getting the painkiller approved and on the market is critical for the company, whose pipeline contains only abuse-deterrent versions of commonly abused painkillers.

Jefferies analyst David Steinberg said he believed Collegium had not infringed Purdue’s patents, pointing to the differences in the formulation of the drugs.

Purdue’s key patents were previously found to be invalid when challenged by other generic drugmakers, he added.

Data on the drugs from Purdue and Collegium were reviewed by a panel of outside advisers to the FDA in September, but only Collegium’s Xtampza ER received a positive opinion.

The companies are competing for a slice of the multi-billion-dollar market for abuse-deterrent prescription painkillers after the FDA decided to remove copycat versions of oxycontin from the market earlier this year.

The abuse of opioids – a class of drugs that include heroin and prescription painkillers – has long been a concern. An overdose of such drugs, which can produce euphoric highs, can disrupt parts of the brain that control breathing.

An estimated 46 people die everyday in the United States from overdosing on opioid painkillers, according to the Centers for Disease Control and Prevention.

Collegium said Xtampza ER can get final approval once the company gets a court order stating that Purdue’s patents are invalid or not infringed, or if Collegium settles the litigation with Purdue within 30 months.

The FDA delayed ruling on the opioid painkiller last month without saying why it was unable to complete its review.

Collegium’s shares, which have gained 84 percent since the company went public in May, closed at $22.09 on Friday.

(Reporting by Ankur Banerjee and Vidya L Nathan in Bengaluru; Editing by Savio D’Souza and Ted Kerr)

Read more at : Reuters

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