Trevena Inc. Gives Oliceridine Approval Another Shot
By Rajaneesh K. Gopinath, Ph.D.
Complying with USFDA’s complete response letter (CRL), the Chesco, Pennsylvania-based biopharma has resubmitted the NDA for its opioid drug with additional study data and validation reports.
After suffering multiple setbacks in the past couple of years, Trevena Inc. has a reason to be optimistic about its lead drug. Today, it has announced the resubmission of New Drug Application (NDA) for intravenous (IV) Oliceridine, an analgesic intended for the management of moderate-to-severe acute pain. Oliceridine is an investigational G protein-selective mu-opioid receptor agonist that has a novel mechanism of action.
Following the advisory committee’s 8-7 vote against the approval, the drug was originally rejected by the FDA in late 2018 on grounds of insufficient safety data. “We continue to believe in the strength of the data and the ultimate approvability of oliceridine” Carrie L. Bourdow, the CEO had said while expressing her disappointment at the time. Soon after, the drug lost its breakthrough therapy designation too.
Trevena suffered another blow when a securities class action lawsuit was filed by Bernstein Liebhard, LLP on behalf of investors who bought the company’s shares between May 2, 2016, and October 8, 2018. The lawsuit accused Trevena of misleading shareholders by claiming successful meetings with the FDA regarding the drug’s Phase III evaluation plans. In reality, the regulatory body had expressed several disagreements with respect to dosing and primary endpoints. As a result, the company’s stocks plummeted several folds.
Adherence to CRL
The FDA had not requested any additional efficacy data in the CRL but had indicated that the submitted safety database is not of adequate size for the proposed dosing. As requested, the resubmitted NDA contained drug product validation reports, data from a multi-dose healthy volunteer QT study with placebo- and positive-control arms and nonclinical data that confirmed levels of an inactive metabolite. As per the agreements with the FDA, a maximum daily dose of 27 mg was specified.
“The resubmission of the Oliceridine NDA represents a significant milestone for the program and an important achievement for the company. I am thankful for the team’s commitment and diligent work to bring us to this exciting point,” said Bourdow. “We appreciate FDA’s guidance through the resubmission process and look forward to continuing to work closely with the Agency as they review our application.”
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