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FDA Advisors Reject Combination Pain Pill Moxduo
The FDA’s Anesthetic and Analgesic Products Advisory Committee has voted unanimously (14–0) to reject Moxduo (QRxPharma), an investigational pain pill that combines two common opioids, oxycodone hydrochloride and morphine sulfate.
The panel ruled that the combination treatment did not offer any clinical advantages over regular oxycodone and morphine. Moreover, public speakers at the April 22 meeting urged that the combination pill be rejected because of its potential for abuse.
The FDA is not obligated to follow the recommendations of its advisory panels, but it usually does so.
Moxduo was initially submitted to the FDA for review in August 2011 with a proposed indication for the management of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The proposed recommended starting dose for Moxduo was from 3 mg/2 mg to 12 mg/8 mg every 4 to 6 hours, as needed, for acute pain.
In June 2012, the FDA issued a complete response letter (CRL) in which the product’s new drug application (NDA) was not approved. The CRL identified a key deficiency, namely that QRxPharma, the developer of Moxduo, had not provided adequate evidence to support that there was a patient population that required treatment with the drug.
After receipt of the CRL, QRxPharma initiated a dialogue with the FDA to clarify the agency’s requirements for approval of Moxduo. Because the product was a combination of two drugs in the same pharmacologic class, the FDA advised that it must demonstrate a benefit, either by showing that Moxduo had greater efficacy than comparable doses of oxycodone or morphine, or that Moxduo was safer than oxycodone or morphine at comparable doses.
During these discussions, it was agreed that this evidence of Moxduo’s benefit might be obtained from Study 022, a trial completed after the original NDA submission. Study 022 was a comparative safety study that evaluated oxygen desaturations in 375 post-bunionectomy patients with moderate-to-severe acute pain who received Moxduo, morphine, or oxycodone.
For the ≤ 80% cut point, 874 desaturation episodes occurred across the three treatment groups. The rates of desaturation SpO2 < 90% were similar but slightly higher for Moxduo compared with morphine and oxycodone. However, for the more severe desaturations (≤ 80%), there was a consistent numerical benefit in the rate observed with Moxduo compared with oxycodone and morphine.
In February 2013, QRxPharma resubmitted the NDA for Moxduo, including a full clinical study report for Study 022. The report contained detailed analyses of oxygen desaturation data from 48 hours of continuous electronic recording of SpO2 values as well as comparative efficacy and safety data.
In its briefing document, QRxPharma claimed that, in terms of efficacy, Moxduo, oxycodone, and morphine were equianalgesic.