Paul Howe is Protega’s Chief Operations Officer.
BATON ROUGE — Louisiana last week became the first state in the nation to mandate the use of certain opioid medications that deter abuse by physical or chemical manipulation when such pills are deemed medically necessary by a physician.
Supporters of the law that took effect on Aug. 1, House Bill 423, say the measure will help thousands of Louisianans who live with chronic pain and have faced obstacles in obtaining effective relief in the wake of prescribing crackdowns during the opioid epidemic.
The new law prohibits any Louisiana insurer from denying a patient what are called immediate-release abuse-deterrent opioid medications. Such drugs provide pain relief like other oxycodone hydrochloride medications, but their formulation resists manipulation that would allow intranasal and intravenous uses of the drug.
Currently RoxyBond, which is manufactured by Protega Pharmaceuticals, is the only drug approved by the Food and Drug Administration that meets the requirements of Louisiana’s new law and guidelines approved by the federal Centers for Disease Control and Prevention (CDC), according to the company.
“It’s the only immediate release abuse-deterrent opioid in the marketplace in the U.S.,” Paul Howe, Protega’s chief operations officer, told the Louisiana Record, adding that its formulation makes it difficult for abusers to “inhale it or inject it or smoke it.”
More than half of the states have considered or are considering similar legislation, and five states – Louisiana, Florida, Maine, Massachusetts and Maryland – have passed such legislation, Howe said.
He stressed that insurance companies in Louisiana are now being required to cover such immediate-release medication when doctors prescribe it. The CDC reports that 24.3% of Americans have a chronic pain issue, and Protega points to studies showing that immediate-release opioids pose a smaller risk for overdose than extended-release opioids.
“We’re not trying to grow the market, we’re just trying to make it safer,” Howe said.
He expects Louisiana, which is expected to receive nearly $70 million from the Purdue Pharma legal settlement in the wake of the opioid epidemic, to see more positive statistics as a result of the new law, including a lower rate of opioid deaths and overdoses.
Doctors, meanwhile, are not as aware as they should be about the availability of Protega’s immediate-release medication, RoxyBond, according to Howe.
“We have a team of people who are educating doctors across the state,” he said. In addition, the company has established outpatient opioid stewardship programs in Louisiana with two of the state’s largest health systems, Ochsner Health and Franciscan Missionaries Health System.
Protega views the new Louisiana law as striking a balance between the need to reduce risks associated with opioid misuse and abuse and the need to provide relief to patients experiencing chronic pain.
The law takes effect as the FDA announced additional labeling requirements for opioid medications to ensure that patients know the risks that come with long-term use of such drugs.
HB 423 was passed by a vote of 95-0 in the state House of Representatives and a vote of 38-0 in the state Senate. Gov. Jeff Landry signed the measure on June 20. Any insurer that violates the new law will be subject to penalties under the Unfair Trade Practices and Consumer Protection Law.
