The FDA Anesthetic and Analgesic Drug Products Advisory Committee will be meeting to evaluate QRxPharma’s revised New Drug Application (NDA) for Moxduo (morphine sulfate and oxycodone hydrochloride). Moxduo’s proposed indication is for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
If approved, Moxduo would be the only fixed-ratio combination oral capsule containing two active opioid ingredients. The proposed Moxduo has been formulated in 3:2 fixed ratios: morphine 3mg/oxycodone 2mg, morphine 6mg/ oxycodone 4mg, morphine 9mg/oxycodone 6mg, and morphine 12mg/oxycodone 8mg.
The FDA has previously not approved a combination drug product comprised of two drugs from the same pharmacologic class due to the Combination Rule, which requires manufacturers to provide safety and evidence of some benefit by the combination of two fixed-dose drugs that cannot be obtained by prescribing the individual medications alone for a significant patient population requiring concurrent therapy.
In the original application, results from a a Phase 2 exploratory study indicated that Moxduo would not be likely to demonstrate improved efficacy over the individual components in a larger trial. While a Phase 3 study of Moxduo did demonstrate efficacy of the combination product, it did not demonstrate a safety benefit and the morphine and oxycodone doses in the comparator arms were lower in potency than the combination product.
The FDA panel will discuss:
- If the Study 22 data provides evidence of a clinically meaningful difference in respiratory safety between Moxduo and morphine and/or Moxduo and oxycodone.
- Whether the overall opioid-related adverse event data provides evidence of a clinically meaningful difference in safety between Moxduo and morphine and/or Moxduo and oxycodone.
- Given the safety data presented, if the Applicant has provided substantial evidence that Moxduo is safer than morphine and oxycodone alone, when used at equipotent doses.
- Given the efficacy data presented, of the the Applicant has provided substantial evidence that Moxduo is more effective than morphine and oxycodone alone, when used at equipotent doses.
- Whether the FDA should approve Moxduo for the treatment of moderate to severe acute pain.
For more information visit FDA.gov.