11-10-2022
Washington, D.C., December 10, 2022 – Modavar Pharmaceuticals announced today that it has launched Paroxetine ER Tablets. The launch of the three strengths of Paroxetine (12.5mg, 25mg and 37.5mg in bottles of 30’s) adds to the growing line of products in the Modavar portfolio.
Paxil® CR belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Serotonin is a monoamine neurotransmitter. Its biological function is complex and multifaceted, modulating mood, cognition, reward, learning, memory, and numerous physiological processes such as vomiting and vasoconstriction. Paroxetine is the most potent and one of the most specific SSRIs. In 2019, it was the 78th most commonly prescribed medication in the U.S., with more than 9 million prescriptions. 8.4% of all U.S. adults had at least one MDD episode, or 21 million people. An estimated 4.7% of U.S. adults experience PD at some time in their lives. An estimated 12.1% of U.S. adults experience SAD at some time in their lives. PMDD affects approximately 2% of women. The total economic burden of MDD is now estimated to be $210.5 billion per year in the U.S. The overall annual direct medical costs associated with anxiety disorders (PD and SAD) is estimated at $33.71 billion. It has been estimated that women with PMDD cumulatively endure 3.8 years of disability over their reproductive years. Given a 14% absenteeism rate and a 15% reduction in productivity, PMDD is associated with $4,333 in indirect costs per patient per year.
Jaswinder (Manji) Matharu, Chairman, stated, “Paroxetine ER tabs is Modavar’s first extended release product launch, and we are excited about being able to provide this antidepressant medication to patients.”
About Modavar Pharmaceuticals
Modavar Pharmaceuticals is an emerging vertically integrated specialty pharmaceutical company that develops, manufactures, and markets generic prescription pharmaceutical products. In collaboration with Cadila Pharmaceuticals Limited, Modavar has a strong pipeline of products, and plans to manufacture ANDA and 505(b)(2) products in its Frederick, Maryland plant as well.
For further information about Modavar Pharmaceuticals, please visit the Company’s corporate website at www.modavar.com.
Safe Harbor
The information in this release may contain various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (“PSLRA”) and which may be based on or include assumptions concerning Modavar’s operations, future results, and prospects. Such statements may be identified using words like “plans”, “expect”, “aim”, “believe”, “projects”, “anticipate”, “commit”, “intend”, “estimate”, “will”, “should”, “could” and other expressions that indicate future events and trends.
All statements that address expectations or projections about the future, including without limitation, statements about the Company’s strategy for growth, product development, regulatory approvals, market position, acquisitions, revenues, expenditures, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the “safe harbor” provisions, Modavar provides the following cautionary statements identifying important economic, political and technology factors which, among others, could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include (but are not limited to) the following: (1) changes in the current and future business environment, including interest rates and capital and consumer spending; (2) the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the possibility that any product launch may be delayed or that product acceptance may be less than anticipated; (6) reliance on key strategic alliances; (7) the availability of raw materials; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in operating results; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company’s customers; (12) the impact of competitive response to the Company’s sales, marketing and strategic efforts; (13) risks that the Company may not ultimately prevail in litigation; and (14) the risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
This discussion is by no means exhaustive but is designed to highlight important factors that may impact the Company’s outlook. We are under no obligation to update any of the forward-looking statements after the date of this report.