The Food and Drug Administration rejected a new painkiller called Moxduo in a unanimous 14-0 decision by advisors — a preventive effort since the painkiller could lead to more drug abuse, they say.
"This is pure morphine and pure oxycodone," said Dr. Andrew Kolodny of the Phoenix House to NPR. "This is a product that is very easy to misuse. Very easy to crush and snort or crush and inject. So it's significantly more dangerous than the products that it would be competing with.”
According to the Centers for Disease Control and Prevention, more than 12 million people reported using prescription painkillers for nonmedical reasons in 2010. One-half of prescription painkiller deaths involve at least one other drug, including benzodiazepines, cocaine, and heroin.
The drug Moxduo contains opioids, morphine, and oxycodone all in one capsule. It’s intended to relieve severe pain from accidents and surgeries.
“The drug allows patients to take lower doses of the two narcotics than they'd need if they took either of the medicines alone,” said Ed Rudnic, COO of QRxPharma, the makers of Moxduo. "We believe that we've achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids."
However, the problem of addiction is still there, especially with such a powerful drug. But Rudnic says that his company will combat any misuse of Moxduo. "I understand abuse and I understand the anguish that some of these people have that have lost a loved one to a drug overdose," Rudnic said. "I lost a brother to a drug overdose in 2002 and it was really tough."
Drug prevention advocates agree saying that a new drug like this will just cause more abuse. "If they get this product put on the market and are able to have a sales force going in and out of doctors' offices encouraging prescribing with the marketing claim that this is somehow a safer product ... I believe that's likely to exacerbate an already severe public health crisis," Kolodny said.