OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of Attention Deficit Hyperactivity Disorder

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NAPERVILLE, Ill., Nov. 17, 2021 (GLOBE NEWSWIRE) – OWP Pharmaceuticals, Inc. is a privately-held, commercial-stage neuroscience pharmaceutical company dedicated to the development and commercialization of novel oral liquid formulations. OWP today announced that it has received IND clearance from the FDA for the first-ever oral suspension of atomoxetine hydrochloride. Offering a significant delivery alternative for a drug often used for attention deficit hyperactivity disorder (ADHD), this represents the fifth of several oral liquid drugs in neuroscience that the company hopes to market in the next few years via a 505 ( b) (2) application, in accordance with its pipeline of reformulated and approved therapeutic products with no currently available liquid formulations.

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor and the capsules, for oral use, were first approved in the United States in 2002. The drug is widely prescribed by health professionals in psychiatry for ADHD, and is indicated for the treatment of children 6 years of age and older. and adults. The efficacy of atomoxetine hydrochloride capsules has been established in seven clinical trials in ambulatory patients with ADHD: four trials of 6 to 9 weeks in pediatric patients (aged 6 to 18 years), two trials of 10 weeks in adults (aged 18 years and over) and a maintenance trial in pediatric patients (aged 6 to 15 years).1 In capsule form, US prescriptions for atomoxetine hydrochloride represent approximately 3 million total prescriptions per year.2

The term “attention deficit hyperactivity disorder” or “ADHD” refers to a neurodevelopmental disorder characterized by inattention, or excessive activity and impulsivity, which are otherwise not age appropriate. of somebody. Some people with ADHD also have difficulty regulating their emotions or have problems with executive function. For a diagnosis, symptoms must appear before a person is 12 years old, be present for more than six months, and cause problems in at least two settings (such as school, home, or recreational activities). In children, attention problems can lead to poor academic performance. In addition, it is associated with other mental disorders and substance abuse. Although this causes disability, especially in modern society, many people with ADHD can have sustained attention to tasks that they find interesting or rewarding (called hyperfocus).

Scott Boyer, Founder and CEO of OWP, said: “Today we are delighted to have received IND approval for our unique formulation of a drug widely used in neuroscience for ADHD patients. . As with our other potential entrants, this alternative dosage form may be preferred by patients of all ages who have difficulty swallowing tablets or capsules or who have difficulty swallowing. Healthcare providers may also find that in this form the drug may be easier to administer and may simplify dosage adjustment. This fifth important strategic initiative, which closely follows the launches of our oral liquid formulations for lamotrigine, topiramate, quetiapine and duloxetine, aligns well with our goal of expanding our single-source and multi-source generic business model. to include more complex generic 505 (b) (2) branded products in our pipeline.

About OWP

Founded in 2014, OWP Pharmaceuticals (www.owppharma.com) provides quality branded and generic neuroscientific drugs. Its strategic goal is to support neurologists, psychiatrists and patients in the United States with commonly used products, and to donate a significant portion of the proceeds to the ROW Foundation (www.rowpharma.org), so that the foundation can provide resources to these people. living with epilepsy and associated psychiatric disorders in underfunded regions of the world.

Caution regarding forward-looking statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements based on the current expectations and assumptions of the management of the Company. . All statements, other than statements of historical fact, included in this press release, including the Company’s belief in the clinical efficacy and safety of the oral liquid formulation of atomoxetine hydrochloride and its ability to improve existing treatment options, are forward-looking statements. You should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those which may be expressed or implied by our forward-looking statements. Forward-looking statements are made as of this date and the Company assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For more information, contact Scott Boyer, Managing Director, at [email protected]

SOURCE OWP Pharmaceuticals, Inc.

Copyright (C) 2021 (GLOBE NEWSWIRE). All rights reserved.

1. STRATTERA® (atomoxetine hydrochloride) capsules, for oral administration. Complete prescribing information. https://uspl.lilly.com/strattera/strattera.html#pi. Accessed April 19, 2021.

2. Symphony Health Data. One-year moving average ending September 2021.


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