In two separate Federal Register (FR) notices today, the FDA announced a public hearing (here) to be held on September 17, 2019. The notice states:
This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.
The notice discusses the desire to develop novel analgesic products that do not have the same addictive properties as opioid drugs, but also acknowledges that despite that desire, the use of opioids is expected to be a mainstay of treating pain until such new products are developed and approved. As the FDA notes, “[P]otent novel analgesics that do not carry the serious risks of existing opioids could greatly reduce or even eliminate the need for opioid analgesics in the armamentarium of drugs available to treat serious pain.” A goal that seems, at this stage, quite a way off.
The second FR notice refers to a new draft guidance (here) entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.” This guidance outlines the FDA’s approach to reviewing and potentially approving future opioid products. It discusses issues relative to abuse potential, packaging options, abuse deterrent formulations (which sometimes pose their own unique safety problems, i.e., excipients causing unintended consequences when being abused (injected, snorted, or swallowed)), efficacy, other safety issues, and a risk-benefit approach the Agency plans to take.
The Agency addresses such risk-benefit relations when the product is used in accordance with its approved labeling or when it is abused. This is the slippery slope the Agency must negotiate, and how it plans to balance the need versus the potential harm that can come from appropriate or inappropriate use of opioid products.
This is an important document that should be read by any firm contemplating entering the opioid market and those that already have approved products on the market since the introduction of new and/or different molecules or abuse-deterrent dosage forms could impact the FDA’s evaluation of the safety, efficacy, and continued marketing of currently approved products.