25 May FDA Rejects Approval of Powerful Moxduo
A key government panel has voted against approval of a powerful opioid prescription painkiller called Moxduo that is said to offer faster relief with fewer side effects than other painkillers on the market.
In April, the Anesthetic and Analgesic Drug Products Advisory Committee for the U.S. Food and Drug Administration (FDA) rejected the application for Moxduo. Moxduo is a strong opioid narcotic painkilling drug manufactured by the pharmaceutical company QRxPharma. The drug combines morphine and oxycodone, two opioid painkillers that are currently manufactured separately under a variety of names.
The decision is a blow for QRxPharma, which saw its stock prices fall following the FDA ruling. However, the decision is a relief to many people working in the field of addiction. With prescription painkiller abuse and addiction a serious and growing problem nationwide, many people feared that the approval of Moxduo would have meant the spread of a drug whose powerful formula would be a serious temptation for prescription drug abusers. Many also feared that the strength of Moxduo would put people who misuse or abuse prescription painkillers at higher risk for accidental overdose.
Arguments for Moxduo
However, Moxduo did have some support in the medical community among people experienced at treating pain. Some experts feel that there is enough legitimate need for new and stronger ways of fighting chronic and acute pain that drugs like Moxduo may be worth the risk.
QRxPharma itself has said that one of the goals of Moxduo is actually to reduce the amount of prescription pain drugs that individual patients need to take. Many patients currently have prescriptions for multiple narcotic painkillers like oxycodone and morphine in order to successfully treat their pain. The drug manufacturer has said that Moxduo would allow these patients to take a single, stronger drug that would equate to a smaller overall opioid dose than single doses of two opioid drugs.
QRxPharma has said that this lower overall dose would permit patients to take enough medication to effectively deal with their pain while experiencing less of the respiratory distress that can often accompany very high doses of opioids, and which is the primary cause of death in many people who overdose on opioid drugs.
Criticism, Doubts About Moxduo
In response to these claims, critics have argued that the strength of individual doses of Moxduo would still be tempting and dangerous for drug abusers. They feel that the presence of a national and international epidemic of opioid painkiller abuse means that new drugs in this field should be viewed and reviewed with extreme scrutiny.
Dr. Joseph Audette of Harvard Medical School told National Public Radio (NPR) that QRxPharma may have the right idea with Moxduo, but that he doesn’t believe the company has sufficiently demonstrated fewer respiratory side effects and equal or greater efficacy compared to the current practice of simply combining the two drugs of which Moxduo is composed.
Furthermore, addiction experts believe that new narcotics seeking FDA approval need to do more than show that they will be effective for patients with serious pain. Prescription drugmakers have adjusted their formulas to make it much more difficult for their pills to be crushed and injected or snorted. OxyContin (oxycodone), for example, used to crush easily into a grainy powder, but now sticks together in clumps when users try to break it apart. It is also much more difficult to dissolve in water.
Moxduo does not contain these kinds of safeguards in its formulation, meaning that it would be much easier for users to abuse than many other opioid painkillers on the market. As a result, addiction experts fear that it would have a worsening effect on what is already a public health crisis.
FDA Cites Lack of Strong Evidence
Ultimately, the FDA advisory committee decided that QRxPharma had not done enough to show that combining morphine and oxycodone into a single product was more effective or safer than taking the drugs separately. The members of the committee said that failings in the creation of the drug’s clinical trials meant that they did not feel confident in the various analyses that concluded Moxduo was comparatively safe and beneficial. They added that the research did not raise any particular red flags about Moxduo, but was simply not convincing enough.
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