OWP Announces Pre-IND Acknowledgement, Patent Application for Schizophrenia, Bipolar Disorder Treatment

OWP Pharmaceuticals has received Pre-Investigational New Drug (PIND) acknowledgement from the U.S. Food and Drug Administration (FDA), and has submitted for U.S. patent protection, for the first-ever liquid formulation of quetiapine fumarate. Offering an important delivery alternative for a drug often used for schizophrenia and bipolar disorder, this represents the third 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.

Quetiapine fumarate is an atypical antipsychotic and the tablets, for oral use, were first approved in the U.S. in 1997. The medication is widely prescribed by adolescent and adult healthcare providers in psychiatry. In schizophrenia, quetiapine fumarate is indicated for treatment in adolescents aged 13 to 17 years and adults. It is also indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex, in adults, and as monotherapy in adolescent patients 10 to 17 years of age. It is also indicated as monotherapy for the acute treatment of depressive episodes in adult patients with bipolar I and bipolar II disorder. Finally, it is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex in adults. In tablet form, U.S. prescriptions for quetiapine fumarate are 15.1 million total prescriptions annually.

"Today we have marked another key milestone for our company with the potential introduction of our third liquid oral suspension which, if approved, would represent the first available for quetiapine fumarate," Scott Boyer, founder and chief executive officer of OWP said. "The potential advantage of this alternative dosage form is that it may be preferred for adult patients who experience swallowing difficulties or for adults and adolescents who have trouble swallowing tablets or capsules. Healthcare providers may also find that in this form, the dosage may be easier to titrate and adjust. This third important strategic initiative, closely following the releases of our oral suspensions for lamotrigine and topiramate, aligns well with our goal of expanding our business model of single source and multisource generics to include more complex 505(b)(2) branded products in our pipeline."

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