This would be the first available oral suspension of lamotrigine, offering a key new delivery option with an easily manageable dose for patients with epilepsy.
OWP Pharmaceuticals has announced that it has received an investigational new drug (IND) approval from the FDA for its first-ever liquid formulation of lamotrigine in the treatment of epilepsy and bipolar disorder.1
The anticonvulsant, which was originally approved in 1994 in the US, is otherwise available as a disintegrating tablet, allowing for this new formulation to offer an important additional delivery option for patients who may struggle with the administration of medication. In oral solid form, there are 10.9 million total lamotrigine prescriptions annually, according to estimates.
“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, OWP, said in a statement. “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.”
This approval comes just days after OWP grabbed another IND go-ahead from the regulatory agency for another epilepsy treatment it developed into a liquid variety, topiramate. The epilepsy and migraine treatment was referred to by Boyer and OWP at the time as “the first of several oral suspensions within the neuroscience space which it plans to commercialize in the coming years.” As was the case with its topiramate formulation, OWP has also applied for patent protection for its liquid lamotrigine agent.
“Today we have marked another key milestone for our company with the potential introduction of our second liquid oral suspension, which, if approved, would represent the first available oral suspension of lamotrigine,” Boyer said. “With the development of an oral suspension of lamotrigine, as well as our oral suspension of topiramate, we hope to establish a leadership position in the creation of novel formulations for patients with neuroscience disorders.”
Lamotrigine is indicated for the adjunctive treatment in patients with epilepsy aged 2 years and older who have partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome (LGS). As well, it has an indication as 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 the maintenance treatment of bipolar 1 disorder in patients who are 18 years of age or older.
“We have built a solid platform to offer even more commonly used neuroscience liquid formulations in the future, all of which will address important unmet needs,” Boyer said in a statement. “This second important strategic initiative aligns well with our goal of expanding our business model of single source and multisource generics to include more complex 505(b)(2) products in our pipeline.”
1. OWP Pharmaceuticals Announces a Second IND Approval and Patent Application: The First-Ever Liquid Oral Suspension Formulation of Lamotrigine for the Treatment of Epilepsy and Bipolar Disorder [press release]. Naperville, IL: OWP Pharmaceuticals; Published December 3, 2019. globenewswire.com/news-release/2019/12/03/1955474/0/en/OWP-Pharmaceuticals-Announces-a-Second-IND-Approval-and-Patent-Application-The-First-Ever-Liquid-Oral-Suspension-Formulation-of-Lamotrigine-for-the-Treatment-of-Epilepsy-and-Bipola.html. Accessed December 3, 2019.
2. OWP Pharmaceuticals Announces IND Approval and Patent Application for the First-Ever Liquid Oral Suspension Formulation of Topiramate for the Treatment of Epilepsy and Migraine [press release]. Naperville, IL: OWP Pharmaceuticals; Published November 20, 2019. globenewswire.com/news-release/2019/11/20/1950056/0/en/OWP-Pharmaceuticals-Announces-IND-Approval-and-Patent-Application-for-the-First-Ever-Liquid-Oral-Suspension-Formulation-of-Topiramate-for-the-Treatment-of-Epilepsy-and-Migraine.html. Accessed December 3, 2019.