LISLE, IL, UNITED STATES, January 12, 2026 /EINPresswire.com/ — OWP Pharmaceuticals today announced commercial product availability of SUBVENITE® (lamotrigine) oral suspension in the United States. The U.S. Food and Drug Administration (FDA) approved SUBVENITE® oral suspension on September 16th, 2025. SUBVENITE® oral suspension is the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer another treatment option 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 options.
“The availability of SUBVENITE® (lamotrigine) oral suspension represents an important advancement in patient care,” said Scott Boyer, Founder and President of OWP Pharmaceuticals. “By offering the first and only liquid lamotrigine formulation in the U.S., we are addressing an unmet need for patients and clinicians who require dosing flexibility without compromising therapeutic reliability, while meeting the unique dosing needs of patients in the U.S. market.”
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 formulation options.
-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].
References:
1. Data on File. OWP Pharmaceuticals, Inc.
2. SUBVENITE® (lamotrigine) oral suspension [package insert]. Lisle, IL: OWP Pharmaceuticals, Inc.; 2025.
About OWP Pharmaceuticals
Established in 2014, OWP Pharmaceuticals (www.owppharma.com) is a privately held, commercial-stage neuroscience specialty pharmaceutical company dedicated to developing and commercializing novel oral liquid formulations. OWP delivers quality branded and generic neuroscience medications with a strategic focus on supporting neurologists, psychiatrists, and patients in the U.S. with commonly used products. In addition, OWP donates a significant portion of its profits to the ROW Foundation (www.rowglobal.org), which provides resources for those living with epilepsy and associated psychiatric disorders in under-resourced areas of the world.
Media Contact:
info@owppharma.com
INDICATION AND BOXED WARNING
SUBVENITE is indicated for:
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.
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of SUBVENITE in the acute treatment of mood episodes has not been established.
WARNING: SERIOUS SKIN RASHES
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine, the active ingredient in SUBVENITE. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
• coadministration with valproate.
• exceeding recommended initial dose of SUBVENITE.
• exceeding recommended dose escalation of SUBVENITE. (5.1)
Benign rashes are also caused by lamotrigine, the active ingredient in SUBVENITE; however, it is not possible to predict which rashes will prove to be serious or life threatening. SUBVENITE should be discontinued at the first sign of rash, unless the rash is clearly not drug related. (5.1)
Please refer to the full Prescribing Information for SUBVENITE at www.subvenite.com.
09/2025
SUBOS1026V1 1/26
Sara Gao
OWP PHARMACEUTICALS
email us here
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
