OWP has received approval for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) 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 healthcare providers in psychiatry who treat adolescent and adult patients. 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 approximately 15.8 million total prescriptions annually.
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“Today we are pleased to have IND approval for our third liquid oral suspension which, if approved, would represent the first available for quetiapine fumarate. 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,” Scott Boyer, founder and chief executive officer of OWP said. “This third important therapeutic option would closely follow the releases of our oral suspensions for lamotrigine and topiramate, and continues to align 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.”