FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults
Amoxicillin PULSYS to be Marketed as Moxatag - First Once-Daily Amoxicillin Product Approved in U.S.
GERMANTOWN, Md., January 24, 2008 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received approval of its New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), for its once-daily Moxatag Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).
The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily Moxatag for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. Moxatag was very well tolerated in the clinical trial.
"We are extremely gratified to have received FDA approval of our Moxatag NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe Moxatag represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."
In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further evaluate its Moxatag product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for Moxatag in pediatric patients less than 12 years old within the next five years as part of this commitment.
"Compared to four times daily penicillin, once-daily Moxatag has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of Moxatag is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."
Clinical Trial Results Summary
The approval of Moxatag was based on MiddleBrook's Phase 3 clinical study of more than 600 adults and pediatric patients 12 years and older in a double- blind, double-dummy, randomized, parallel-group, 50-center non-inferiority trial. The Company compared its Moxatag tablet for the treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes (Group A streptococcus) delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days.
Bacteriological eradication at the post-therapy test-of-cure visit in the per-protocol population was 85.0 percent (198/233) of patients with Moxatag and 83.4 percent (191/229) with penicillin. These results demonstrate statistical non-inferiority (95 percent confidence interval of -5.1, 8.2). The per-protocol patient population included patients with confirmed Group A streptococcal infections, who were compliant with treatment and did not have major protocol violations. Other results from the trial were consistent with the per-protocol population, with Moxatag therapy demonstrating statistical non-inferiority to the comparator therapy in all primary and secondary endpoints.
Important Safety Information
Moxatag is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older.
Moxatag is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Moxatag, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Moxatag should be discontinued and appropriate therapy instituted.
Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
In a controlled U.S. clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature. The most frequently reported adverse reactions (> 1%) which were suspected or probably drug- related were vaginal yeast infection (2.0%), diarrhea (1.7%), nausea (1.3%), and headache (1.0%).
Safety and effectiveness of Moxatag in pediatric patients less than 12 years of age has not been established.
Moxatag (amoxicillin extended-release tablets) is a once-a-day extended- release formulation of amoxicillin for oral administration consisting of three components: one immediate-release and two delayed-release. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin.
Moxatag is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. MiddleBrook utilized its proprietary PULSYS once-daily pulsatile delivery technology to develop Moxatag. The company currently has a total of 26 issued U.S. patents and two issued foreign patents covering its PULSYS technology. Patents specifically relating to Moxatag run to 2020.
Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). Group A streptococcus, the primary bacteria causing pharyngitis, have been uniformly susceptible to amoxicillin and have not developed resistance to the penicillins, despite the long-term use of amoxicillin for pharyngitis.
According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children. Approximately 60 million prescriptions for amoxicillin were written in 2006 with total retail sales of more than $650 million. For pediatricians, amoxicillin is the most prescribed drug among all therapeutic classes. Among family physicians, amoxicillin is the twelfth most prescribed drug among all therapeutic classes.
The most commonly prescribed treatment for the management of Group A streptococcal pharyngitis is 500 milligrams of amoxicillin dosed three-times daily for a period of 10 days. With the FDA approval of Moxatag, physicians now have available the first once-daily product in the aminopenicillin class for the treatment of pharyngitis while utilizing approximately one-half the amount of amoxicillin currently used.
Pharyngitis is a painful inflammation of the throat caused by a variety of microorganisms, both viral and bacterial. About 15 million patients annually seek relief of sore throat symptoms in the United States. The most common bacterial cause of acute pharyngitis is Streptococcus pyogenes, or Group A streptococcus, which is referred to as "strep throat." Symptoms of strep throat include fever, painful swallowing, swelling of the throat, and headache. Symptomatic strep throat can lead to complications, such as rheumatic fever, and should be treated with antibiotic therapy. Pharyngitis ranks in the top ten diagnoses made by pediatricians, family physicians, and emergency medicine specialists.
About Middlebrook Pharmaceuticals
MiddleBrook Pharmaceuticals, Inc. is a pharmaceutical company focused on the development and commercialization of anti-infective drug products that fulfill substantial unmet medical needs in the treatment of infectious disease. The Company is developing anti-infective drugs based on its novel biological finding that bacteria exposed to antibiotics in front- loaded staccato bursts, or "pulses," are killed more efficiently and effectively than those under standard treatment regimens. Based on this finding, MiddleBrook has developed a proprietary, once-a-day pulsatile delivery technology called PULSYS. By applying its delivery technologies, MiddleBrook has the potential to improve drug efficacy, shorten length of therapy, and reduce drug resistance versus currently available antibacterial products.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on MiddleBrook's current expectations and assumptions. These statements are not guarantees of future performance and are subject to a number of risks and uncertainties that would cause actual results to differ materially from those anticipated. The words, "believe," "expect," "intend," "anticipate," and variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward- looking. Statements in this announcement that are forward-looking include, but are not limited to, statements about the Company's future development plans, clinical trials, potential commercial success, and any financial forecasts included in this announcement.
The actual results realized by MiddleBrook could differ materially from these forward-looking statements, depending in particular upon the risks and uncertainties described in the Company's filings with the Securities and Exchange Commission. These include, without limitation, risks and uncertainties relating to the Company's financial results and the ability of the Company to (1) raise additional capital and continue as a going concern, (2) increase Keflex 750 sales, (3) retain marketing approval for its Moxatag product, (4) successfully reduce costs, (5) reach profitability, (6) prove that the preliminary findings for its product candidates are valid, (7) receive required regulatory approvals, (8) successfully conduct clinical trials in a timely manner, (9) establish its competitive position for its products, (10) develop and commercialize products that are superior to existing or newly developed competitor products, (11) develop products without any defects, (12) have sufficient capital resources to fund its operations, (13) protect its intellectual property rights and patents, (14) implement its sales and marketing strategy, (15) successfully attract and retain collaborative partners, (16) successfully commercialize and gain market acceptance for its Keflex products, (17) successfully obtain sufficient manufactured quantities of its drug products at acceptable rates, and (18) retain its senior management and other personnel. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. MiddleBrook undertakes no obligation to update or revise the information in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Posted: January 2008
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