Three Pharma Companies Seek to Address FDA Rejections



Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application (NDA) for oral sulopenem, which has been developed to treat uncomplicated urinary tract infections (uUTI).

On Friday, Chief Executive Officer Corey Fishman said the company had requested a Type B meeting with the U.S. Food and Drug Administration (FDA) regarding designing a Phase III trial of oral sulopenem that could lead to a resubmission of the NDA. In July, the FDA hit Iterum with a Complete Response Letter (CRL), rejecting the company’s application for regulatory approval.

The FDA noted that, in the Phase III SURE-1 study, there was a statistical significance in the difference in the overall response rate of oral sulopenem compared to the antibiotic drug ciprofloxacin in the ciprofloxacin-resistant population.

According to the FDA, additional data was necessary before it could approve the medication. Specifically, the FDA is seeking data that will support approval for treating adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone. To achieve this, the FDA recommended another clinical study using a different comparator drug. Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen.

Illinois-based Eton Pharmaceuticals is also moving forward with plans to seek regulatory approval following a CRL. Earlier this year, the FDA issued the CRL for Eton’s dehydrated alcohol injection to treat methanol poisoning.

The FDA’s rejection largely centered on issues concerning the company’s European contract manufacturer. According to the letter, travel restrictions related to the ongoing COVID-19 pandemic prevented the FDA from inspecting the manufacturing facility ahead of the PDUFA date. That was an issue that plagued multiple companies over the past year.

On Monday, Eton said in its third-quarter financial report that the company held a meeting with the FDA to discuss the Complete Response Letter and its efforts to respond to the regulatory agency.

“Based on the positive outcome of the meeting, Eton believes the FDA’s requests are fully addressable, and the company expects to submit its response as an amendment in the coming months,” the company said in its announcement.

San Diego-based Acadia Pharmaceuticals is also continuing efforts to address a CRL issued by the FDA earlier this year. In April, the FDA rejected Acadia’s supplemental New Drug Application for Nuplazid, which had previously been approved for hallucinations and delusions associated with Parkinson’s disease psychosis. The company hoped to expand the label to include hallucinations and delusions associated with dementia-related psychosis.

However, that was stymied by the FDA, which said the company’s clinical data lacked statistical significance in some of the dementia subgroups. The FDA claimed not enough patients with specific less common dementia subtypes failed to show effectiveness.

When the CRL was issued, Acadia said it had a previous agreement with the Division of Psychiatry over the study design for the pivotal Phase III trial, which included a broad dementia-related psychosis patient population analyzed as a single group.

In its quarterly report issued earlier this month, has scheduled a meeting with the FDA to discuss additional analyses supporting a potential resubmission of the sNDA focused on specific subgroups of dementia. The company said it will provide an update following the meeting, held at the end of the year.

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