(Bloomberg) -- Backed by a U.S. campaign to slow abuse of prescription painkillers, drugmakers are devising new forms of the medicines that don’t lead to misuse and new products that treat dependency in a bid to change the face of a $9.4 billion market.
Orexo AB is working on a drug that blocks opiate receptors in the nervous system, potentially lessening addict dependence. Nektar Therapeutics on June 19 announced positive study results on an experimental medicine designed to enter the brain slowly, reducing the euphoria that can lead to addiction. And in April, the U.S. barred copies of the original form of OxyContin after Purdue Pharma LP proved its crush-resistant version made the therapy less valuable to addicts on the street.
“We are not wedded to any one way or the other” to stop the abuse, Douglas Throckmorton, deputy director for regulatory programs at the FDA, says in a telephone interview. “What we want is abuse-deterrent formulations that work. We know how important this is.”
The FDA isn’t the only U.S. agency involved in the drive to slow the abuse epidemic. The Drug Enforcement Agency on June 11 fined Walgreen Co., the largest U.S. drugstore chain, $80 million after a probe into whether it violated rules governing the distribution of the pills.
The number of women who died from an overdose of prescription painkillers jumped almost fivefold from 1999 to 2010, the Centers for Disease Control and Prevention said in a briefing today. The deaths totaled almost 48,000.
“It’s getting worse, and it’s getting worse quickly,” CDC director Thomas Frieden says, adding that pain medicine abuse “has skyrocketed in the past decade.”
Painkiller abuse also has driven up the cost of insurance claims, a trend that the industry has been studying, says Robert Benmosche, chief executive officer of New York-based American International Group Inc., one of the largest U.S. providers of
“People are desperate for their painkillers, and there was no algorithm in process for us to deal with people who we saw that were abusing that,” Benmosche says. The insurer has been evaluating data with Johns Hopkins University in Baltimore as part of an effort to help “drive people back to work,” he says.
OxyContin sales made up about $2.81 billion of the $9.38 billion U.S. market for prescription painkillers in 2012, according to IMS Health Inc., a health care data provider based in Danbury, Conn.
The FDA decision banning generic-drug makers from copying the original form of OxyContin was critical to the fight against the epidemic, says Rep. Bill Keating, a Massachusetts Democrat who is sponsoring legislation designed to block any new drug, including generics, lacking tamper-resistant properties.
Without that FDA ruling in support of Purdue’s OxyContin reformulation, generic-drug makers “would’ve been going forward with a whole new supply of drugs that were dangerous and cheaper, and undoubtedly would have resulted with a geometric increase of deaths,” Keating says in a telephone interview.
“In Massachusetts, almost two people a day die from prescription drug overdose,” he said. “In some parts of the country like Appalachia and Kentucky, it’s so pronounced that 10% of babies are born addicted.”
