Allegra-D 24 HourTreatment for Allergic Rhinitis, Nasal Congestion
New Drug Application Submitted for Once-Daily Allegra-D (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg) Formulation Using aaiPharma's Development Expertise
WILMINGTON, N.C., January 15, 2004, -- aaiPharma Inc., today confirmed Aventis' submission of a new drug application (NDA) to the FDA for Aventis' Allegra-D 24 hour tablets (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg), a formulation developed with aaiPharma using a patented extended release drug delivery technology, ProSlo II(TM), developed by Osmotica. Aventis is seeking approval for a once-daily formulation for the treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older. Aventis currently markets twice-daily Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) extended release tablets.
The once-daily technology platform used in the Allegra-D NDA submission was developed by aaiPharma's collaborative partner, Osmotica. aaiPharma and Osmotica collaborate around the use of patented osmotic technology for drug development.
"The submission of an NDA for a product as important as Allegra-D using aaiPharma development expertise reinforces our unique drug development capabilities," said Dr. Vijay Aggarwal, President, Research and Development for aaiPharma. "The submission also confirms aaiPharma's strategy to utilize our significant development capabilities to benefit not only our own pharmaceutical pipeline, but also the product development needs of our pharmaceutical partners."
Side effects with Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) extended release tablets were similar to Allegra alone and may include headache, insomnia, and nausea. Due to the decongestant (pseudoephedrine) component in Allegra-D, this product must not be used if you: are taking an MAO inhibitor (a medication for depression) or have stopped taking an MAO inhibitor within 14 days; retain urine; have narrow-angle glaucoma; have severe high blood pressure or severe heart disease.
You should also tell your doctor if you have high blood pressure, diabetes, heart disease, glaucoma, thyroid disease, impaired kidney function, or symptoms of an enlarged prostate such as difficulty urinating.
aaiPharma Inc. is a leading, science-based pharmaceutical company focused on pain management, with corporate headquarters in Wilmington, North Carolina. With more than 24 years of drug development expertise and a proven sales and marketing track record, the Company is focused on developing, acquiring, and marketing well-known, branded medicines in its targeted therapeutic areas. aaiPharma 's development efforts are focused on developing improved medicines from established molecules through its significant research and development capabilities. For more information on the Company, including its product development organization AAI Development Services, please visit aaiPharma's website at www.aaipharma.com
Osmotica is a pharmaceutical research and development company, with more than 15 years of leadership experience in the area of controlled release formulations with operations in both North and South America. Osmotica currently provides to its marketing partners, for registration or sale, more than five different products in 15 countries around the world. Osmotica offers innovative osmotic tablet technology to the international pharmaceutical industry for the improvement of product profiles and extension of their life cycle. For more information about Osmotica, please visit our website at www.osmoticausa.com
Forward Looking Statements
Information in this press release contains certain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, including the quoted statements by Dr. Aggarwal. The "forward-looking statements" herein involve risks and uncertainties that could cause actual results to differ materially, including, without limitation, risks and uncertainties pertaining aaiPharma's ability to use its development capabilities to timely and successfully develop, improve, obtain timely regulatory approval for, and profitably sell pharmaceutical products and services. Additional factors that may cause the actual results to differ materially are discussed in aaiPharma's recent filings with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K filed on March 28, 2003, including its exhibits; its Forms 10-Q filed on May 15, 2003, August 14, 2003 (including its Exhibit 99.1) and November 14, 2003, its Form 8-Ks; and its other periodic filings.
CONTACT: Media, Andrea L. Johnston, Vice President, CorporateCommunications, +1-910-254-7340, or Investors, James B. Sloan, Jr. Senior VicePresident, Corporate Finance, +1-910-254-7690, both of aaiPharma Inc.
Posted: January 2004
- Allegra-D 24 Hour Aventis Pharmaceuticals Inc. - Treatment for Seasonal Allergy Symptoms with Nasal Congestion - October 19, 2004