OWP has applied for U.S. patent protection for the first-ever oral solution of trazodone, the sixth liquid medication that the company hopes to commercialize.
NAPERVILLE, ILLINOIS, USA, November 30, 2022 /EINPresswire.com/ — OWP Pharmaceuticals, Inc. is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations. OWP announced today that it has applied for U.S. patent protection for the first-ever oral solution of trazodone hydrochloride. Offering an important delivery alternative for a drug often used for major depressive disorder (MDD), this represents the sixth of several oral liquid medications 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.
Trazodone hydrochloride is a selective serotonin reuptake inhibitor and the tablets, for oral use, were first approved in the U.S. in 1981. The medication is widely prescribed by healthcare providers in psychiatry for MDD, and it is indicated for treatment in adults. The efficacy and safety of trazodone hydrochloride was established from both inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder. (1) In tablet form, total U.S. prescriptions for trazodone hydrochloride are approximately 35.8 million annually. (2)
Scott Boyer, founder, and chief executive officer of OWP stated, “Today we are pleased to have filed a patent application for our unique formulation of a drug widely used in neuroscience for patients challenged with MDD. As with our other potential entrants, this alternative dosage form may be preferred by patients who have trouble swallowing tablets or who experience swallowing difficulties. Healthcare providers may also find that in this form, the medication may simplify dosage titration or combination therapy. This sixth important strategic initiative, closely following the releases of our oral liquid formulations for lamotrigine, topiramate, quetiapine, atomoxetine, and duloxetine, aligns well with our goal of expanding our business model to include more complex 505(b)(2) branded products in our pipeline.”
Established in 2014, OWP Pharmaceuticals (www.owppharma.com) delivers quality branded and generic neuroscience medications. Its strategic focus is to support neurologists, psychiatrists, and patients in the U.S. with commonly used products, and to donate a significant portion of the profits to the ROW Foundation (www.rowglobal.org) for the provision of resources to those living with epilepsy and associated psychiatric disorders in under-resourced areas of the world.
Cautionary Note Regarding Forward-Looking Statements
This news 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 that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release, including the Company’s belief of the clinical efficacy and safety of trazodone hydrochloride oral liquid formulation and its ability to improve upon 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 that may be expressed or implied by our forward-looking statements. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Scott Boyer, Chief Executive Officer, at Scott.Boyer@owppharma.com.
SOURCE OWP Pharmaceuticals, Inc.
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- DESYREL® (trazodone hydrochloride) tablets, for oral use. Full prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf. Accessed November 15, 2022.
- Symphony Health Data. One year rolling average ending September 2022.
Scott Boyer, CEO
OWP Pharmaceuticals, Inc.
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