Extensive new draft guidance released this week by the US Food and Drug Administration (FDA) makes formal recommendations on how sponsors of analgesic painkillers should develop their products in preparation for eventual marketing authorization.
The 35-page draft guidance, Analgesic Indications: Developing Drug and Biological Products, is intended for sponsors of analgesic products intended to treat acute, chronic and breakthrough pain.
All three types of pain-acute, chronic and breakthrough-are characterized by the need for long-term, regular treatment with analgesics. FDA notes that while it is important to understand how a single dose of the drug works, it's even more interested in understanding how the drug functions as part of a long-term regimen.
The guidance contains a plethora of advice for companies seeking ultimate approval.
"Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs," FDA explained in the preamble of the guidance.
One early consideration noted by FDA is the type of pain indication being sought by a sponsor. Regulators recommended that sponsors meet with FDA prior to the initiation of a Phase 3 clinical study to discuss proposed indications and whether or not they are feasible to obtain.
From there, FDA recommends four general approaches based on a novelty scale ranging from the newest drugs (i.e. New Molecular Entities), to reformulated drugs, add-on indications and additional claims.
Those approaches are then broken down by the type of pain experienced by patients, with FDA recommending specific approaches for each.
The guidance also speaks to various stages of clinical development, including the considerations each stage of a clinical trial should take into account with respect to safety, endpoints, patient populations, trial designs, routes of drug administration and more.
Comments on the guidance should be submitted to FDA by 7 April 2014.
Analgesic Indications: Developing Drug and Biological Products