OWP Announces Second IND Approval for Lamotrigine Liquid Oral Suspension Formulation

OWP Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and has submitted for U.S. patent protection, for the first liquid formulation of lamotrigine. Offering an important delivery alternative for a drug often used for epilepsy and bipolar disorder, this represents the second of several oral suspensions in neuroscience that the company hopes to commercialize over the next several years via a 505(b)(2) application, in keeping with its pipeline of reformulated, approved therapeutics with no currently available liquid formulation.

Lamotrigine tablets, for oral use, were first approved in the U.S. in 1994 and the medication is widely prescribed by pediatric and adult healthcare providers in neurology and psychiatry. In epilepsy, lamotrigine is indicated for adjunctive therapy in patients aged 2 years and older who have partial onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome. It is also indicated for conversion to monotherapy in patients aged 16 years and older with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Finally, it is indicated for maintenance treatment of bipolar 1 disorder in patients who are 18 years of age or older. In oral solid form, U.S. prescriptions for lamotrigine are 10.9 million total prescriptions annually.

"Pediatric clinicians who regularly treat children and adolescents with epilepsy often find that their patients have trouble with or are afraid of swallowing tablets," Scott Boyer, founder and chief executive officer of OWP said. "We believe that the availability of a liquid formulation of lamotrigine for which parents can easily manage the dose, could be helpful to their practices and their patients."

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