Product
Moxatag
Approval Date
Jan. 23, 2009
Release Date
March 16, 2009
Company
MiddleBrook Pharmaceuticals, Inc.
Class
Aminopenicillin
Indication
Once-daily extended-release Tablets, 775mg amoxicillin for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.
Active Ingredient
Amoxicillin
Agency Roster
Dudnyk Healthcare
Marketing Strategy/Execution
Awareness of Moxatag will be raised through physicians, pharmacists, managed care and other key stakeholders. Marketing programs will include direct mail, digital media, and journal advertising.
The Company has hired over half of its 270-person field force which will promote Moxatag to healthcare professionals nationwide. MiddleBrook also announced that it completed its manufacturing validation of Moxatag, and in preparation for the Moxatag trade launch, Moxatag shipments to the company’s third-party logistics provider began in January 2009.
MiddleBrook plans to hire sales representatives to fill the remaining open positions for its field force over the next several weeks.
Physician Outlook
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. Not likely to make a significant impact on the market but, in this heavily antibiotic resistant environment, another choice for physicians to consider.
— Sue Ramspacher, Sr. Vice President, Category Business Leader, GfK Healthcare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: HMR 3647
Manufacturer: sanofi-aventis
Indication: Acute exacerbations of chronic bronchitis
Active ingredient: Telithromycin
Phase: Launched
Source: Wolters Kluwer Health
MiddlebrookPharma adds 271 reps
ThomsonReuters names five most promising Q1 drugs
Pharmacology
Moxatag is a once-daily formulation of amoxicillin with a unique dosage strength that is indicated for treating pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes. This extended-release tablet consists of three components: one is immediate-release and two are delayed-release. The rate of absorption of amoxicillin from this product is slower than that of immediate-release amoxicillin suspension, but total exposure of the drug from Moxatag is similar to that of a comparable dose of amoxicillin immediate-release oral suspension.
Amoxicillin is a semi-synthetic antimicrobial belonging to the penicillin class with activity against gram (+) bacteria. Like other penicillins, amoxicillin exerts its antibacterial effect by interfering with the production of cell wall mucopeptides in multiplying bacteria.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxatag and other antibacterial drugs, Moxatag should be prescribed only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Clinical Trials
A randomized, parallel-group, double-blind study was conducted in patients 12 years of age and older who had been diagnosed with pharyngitis and/or tonsillitis secondary to S. pyogenes. Moxatag 775mg once daily for 10 days was shown to be as effective as penicillin VK 250mg four times daily for 10 days. In an intent-to-treat analysis, those patients who were found to have had a positive throat culture for S. pyogenes at baseline and were treated with Moxatag had a 79.7% bacteriological eradication rate, compared to 78.0% for those treated with penicillin VK. For those patients who had post-therapy cultures, were compliant with treatment, and who had no major protocol variations, Moxatag therapy was associated with an 85% bacteriological eradication rate, compared to 83.4% for penicillin VK.
Adverse Reactions
GI upset, headache; hypersensitivity reactions (eg, rash, Stevens Johnson syndrome, anaphylaxis, urticaria), superinfection, hyperactivity, blood dyscrasias, pseudomembranous colitis.
Adults
Take with food. Swallow whole. 775mg once daily for 10 days.
Children
Not recommended.
Precautions
Have epinephrine available. Cephalosporin, imipenem, other allergy or mononucleosis: not recommended. Severe renal impairment (CrCl <30mL/min); hemodialysis: not recommended. If serious diarrhea occurs, discontinue therapy. Pregnancy (Cat.B). Labor & delivery. Nursing mothers.
Interactions
Potentiated by probenecid. May cause false (+) glucose with Clinitest, Benedict’s, or Fehling’s soln. May reduce efficacy of oral contraceptives. May be antagonized by bacteriostatic antibiotics (eg, tetracyclines, sulfonamides, macrolides).
