trending Market Intelligence /marketintelligence/en/news-insights/trending/BiUA8l-gIWGp4EioqjuH7Q2 content esgSubNav
In This List

US FDA declines to review Cumberland's updated application for pain drug

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


US FDA declines to review Cumberland's updated application for pain drug

Cumberland Pharmaceuticals Inc. said the U.S. Food and Drug Administration declined to review its updated application for pain drug Caldolor due to the number of new claims.

Caldolor is already approved to treat patients with mild to moderate pain, moderate to severe pain as an adjunct to opioid analgesics, and fever.

Cumberland is looking to market the drug in a new, patented formulation and a more convenient package. The proposed revised label would also include a class label update on the use of non-steroidal anti-inflammatory drugs — the drug class under which Caldolor belongs — with aspirin.

To support its proposed label expansion, the company submitted clinical trial data on optimal infusion time, safety information, plus administration for geriatric and pediatric patients.

The Nashville, Tenn.-based company's application was rejected in Aug. 2, 2018 by the U.S. regulator, which requested additional quality and nonclinical data. Cumberland subsequently submitted an amended application on Sept. 26, 2018.

Regarding the current rejection, Cumberland said the U.S. FDA recommended splitting up the single submission into several separate ones, with each submission containing a single labeling claim or group of related labeling claims, with data to support each claim.

The company said it is evaluating the regulator's response and has offered the FDA a type A meeting to discuss the recommendations.