Naperville-based OWP Pharmaceuticals, a company focused on developing new treatments for neurological conditions,announced a significant step forward today. The U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for SUBVENITE® (lamotrigine) oral suspension.

This is a major development for both OWP and patients struggling with epilepsy and bipolar disorder. SUBVENITE® has the potential to be the first FDA-approved oral liquid lamotrigine medication in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of January 3rd, 2025.

“We are incredibly excited to have received FDA acceptance of our NDA,” said Scott Boyer, founder and CEO of OWP.“This brings us closer to bringing the first oral liquid lamotrigine to the US market, offering a new option for patients who may find traditional tablets difficult to swallow.”

This achievement marks a significant milestone for OWP Pharmaceuticals. It represents the first NDA acceptance for the company, which has a robust pipeline of six additional oral liquid medications under development. These medications are being developed through a 505(b)(2) pathway and include lamotrigine, topiramate, quetiapine fumarate, trazodone hydrochloride, atomoxetine hydrochloride, and duloxetine hydrochloride.

The potential benefits of a lamotrigine oral suspension are numerous. For patients who have difficulty swallowing pills,an oral liquid could significantly improve medication adherence and treatment outcomes. This could be especially impactful for children and elderly patients.

With the FDA’s acceptance of the NDA, OWP Pharmaceuticals is one step closer to offering a new treatment option for patients with epilepsy and bipolar disorder. The coming months will be crucial as the company works towards the PDUFA date of January 3rd, 2025.

Read the press release

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