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FDA Approves Subvenite

FDA Approves Subvenite (lamotrigine) Oral Suspension for Epilepsy and Bipolar Disorder

September 2025

LISLE, IL, UNITED STATES, September 17, 2025 /EINPresswire.com/ -- OWP Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Subvenite Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets.

Lamotrigine is widely prescribed, but until now only solid oral dosage forms have been available. Subvenite Oral Suspension is designed for patients who have difficulty swallowing tablets, those who require individualized dosing, or prefer liquid medication formulations.

“The FDA approval of Subvenite Oral Suspension — the first and only lamotrigine oral suspension — represents a significant advancement in patient care,” said Scott Boyer, Founder and President, OWP Pharmaceuticals. “We are proud to bring this much needed treatment option to patients and clinicians, with availability anticipated later in 2025.”

Key Features and Benefits of Subvenite Oral Suspension:
- First and only FDA-approved lamotrigine oral suspension in the U.S.
- Improved accessibility: Suitable for patients with swallowing challenges, those requiring individualized dosing, or those who prefer liquid medication formulations.
- Precision dosing: Liquid formulation allows for dose titration and flexibility.
- Therapeutic reliability: Developed to deliver the expected safety and efficacy profile as lamotrigine tablets (1).

Availability
Subvenite Oral Suspension has been FDA-approved and is expected to be available in the United States later in 2025 through leading distribution channels. Full prescribing information is available at www.owppharma.com.

Indications
Subvenite is indicated for (2):
Epilepsy - adjunctive therapy in patients aged 2 years and older:
• partial-onset seizures
• primary generalized tonic-clonic (PGTC) seizures
• generalized seizures of Lennox-Gastaut syndrome.

Epilepsy - monotherapy in patients aged 16 years and older:
• Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.

Bipolar disorder:
• Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

About OWP Pharmaceuticals
OWP Pharmaceuticals is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations. Based in Chicago, OWP is committed to advancing therapies in neurology and psychiatry, with a mission to bring meaningful innovations to patients. Through its partnership with the ROW Foundation, OWP also supports global initiatives to improve epilepsy care and education in underserved communities worldwide.

References:
1. DOF: Data on File. OWP Pharmaceuticals, Inc.
2. Subvenite® Oral Suspension [package insert]. Lisle, IL: OWP Pharmaceuticals, Inc.; 2025.

Source: OWP Pharmaceuticals

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