OWP Pharmaceuticals has submitted for U.S. patent protection for the first powder for oral liquid formulation of duloxetine hydrochloride. Offering an important delivery alternative for a drug often used for major depressive and generalized anxiety disorder, this represents the fourth of several oral liquid options in neuroscience that the company hopes to commercialize over the next several years via 505(b)(2) applications, in keeping with its pipeline of reformulated, approved therapeutics with no currently available liquid formulation.

Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) and the delayed-release capsules, for oral use, were first approved in the U.S. in 2004. The medication is widely prescribed by healthcare providers in psychiatry. In major depressive and generalized anxiety disorders, duloxetine hydrochloride is indicated for treatment in adults. It is also indicated in adults for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy, fibromyalgia (FM), and chronic musculoskeletal pain, established in studies in patients with chronic low back pain and chronic pain due to osteoarthritis. In delayed-release capsule form, U.S. prescriptions for duloxetine hydrochloride are over 24 million total prescriptions annually.

“Today we have marked yet another key milestone for our company with the potential introduction of our fourth unique formulation of another drug widely used in neuroscience. If approved, this would represent the first-ever powder for oral liquid formulation available for duloxetine hydrochloride. As with our other potential entrants, this alternative dosage form may be preferred by adult patients who experience swallowing difficulties or 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 fourth important strategic initiative, closely following the releases of our oral liquids for lamotrigine, topiramate, and quetiapine, 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,” Scott Boyer, founder and chief executive officer of OWP said.