MOXATAG: Clinical Trials, Market Analysis, and Projections
Introduction to MOXATAG
MOXATAG, an extended-release formulation of amoxicillin, is a penicillin-class antibacterial drug approved by the FDA in 2008 for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older[1][5].
Clinical Trials Overview
The FDA approval of MOXATAG was based on a Phase 3 clinical study involving more than 600 patients. This double-blind, double-dummy, randomized, parallel-group trial compared the efficacy and safety of MOXATAG (775 mg once daily for 10 days) to penicillin VK (250 mg four times daily for 10 days)[1].
Efficacy Results
The trial demonstrated that MOXATAG was statistically non-inferior to penicillin VK in eradicating the bacteria responsible for strep throat. The bacteriological eradication rates at the post-therapy test-of-cure visit were 85.0% for MOXATAG and 83.4% for penicillin VK, with a 95% confidence interval of -5.1 to 8.2[1].
Safety and Tolerability
MOXATAG was well tolerated in the clinical trial. The majority of treatment-emergent adverse reactions were mild and transient, with similar frequencies reported in both treatment groups. Discontinuation due to drug-related adverse reactions occurred in 1.3% of MOXATAG-treated patients and 3.3% of penicillin VK-treated patients[1][4].
Market Analysis
Target Market
The target market for MOXATAG is estimated to be between two and three million prescriptions annually for patients 12 years of age or older treated by primary care physicians. According to IMS Health data, approximately three million patients in this age group are treated with amoxicillin each year for tonsillitis and/or pharyngitis secondary to S. pyogenes[5].
Market Positioning
MOXATAG is the first and only FDA-approved once-daily formulation of amoxicillin, offering a significant convenience advantage over traditional multiple-dose regimens. This once-daily dosing is expected to improve patient compliance, a critical factor in the effective treatment of bacterial infections[1][5].
Competitive Landscape
The U.S. antibiotic market for treating tonsillitis and/or pharyngitis is competitive, but MOXATAG's unique once-daily dosing schedule sets it apart from other amoxicillin formulations. Vernalis Therapeutics, the current promoter of MOXATAG, highlights this convenience as a key selling point, particularly for primary care physicians[5].
Market Projections
Prescription Volume
Given its unique dosing regimen and the large target market, MOXATAG is projected to capture a significant share of the prescriptions for tonsillitis and/or pharyngitis in patients 12 years and older. The estimated annual prescription volume is between two and three million, which could translate into substantial revenue for the drug[5].
Revenue Potential
While specific revenue projections for MOXATAG are not publicly available, the drug's market position and the size of the target market suggest significant revenue potential. The convenience of once-daily dosing is likely to drive adoption among both physicians and patients, contributing to its market success.
Safety and Contraindications
Contraindications
MOXATAG is contraindicated in patients with known serious hypersensitivity to amoxicillin or other drugs in the same class, as well as those who have demonstrated anaphylactic reactions to beta-lactams[1][3].
Adverse Reactions
The most frequently reported adverse reactions include gastrointestinal disorders such as diarrhea, and infections like vulvovaginal mycotic infection. However, these reactions are generally mild and transient[1][4].
Dosage and Administration
The recommended dose of MOXATAG is 775 mg once daily, taken within 1 hour of finishing a meal, for a total of 10 days. Patients should not chew or crush the tablets[3].
Patent and Intellectual Property
MiddleBrook Pharmaceuticals, the original developer of MOXATAG, holds a total of 26 issued U.S. patents and two issued foreign patents covering its PULSYS technology, which is used in the development of MOXATAG. These patents run until 2020[1].
Current Promoter and Distribution
Vernalis Therapeutics, Inc. acquired the U.S. rights to MOXATAG from Pragma Pharmaceuticals, LLC in 2015 and began promoting the drug to primary care physicians in the U.S. in 2016[5].
Key Takeaways
- Clinical Efficacy: MOXATAG demonstrated statistical non-inferiority to penicillin VK in eradicating S. pyogenes in clinical trials.
- Market Position: It is the first and only FDA-approved once-daily formulation of amoxicillin, offering improved convenience and compliance.
- Target Market: Estimated between two and three million prescriptions annually for patients 12 years and older.
- Safety: Generally well tolerated with mild and transient adverse reactions.
- Contraindications: Patients with serious hypersensitivity to amoxicillin or beta-lactams.
FAQs
What is MOXATAG used for?
MOXATAG is used for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older.
How is MOXATAG administered?
MOXATAG is administered as a 775 mg tablet once daily, taken within 1 hour of finishing a meal, for a total of 10 days.
What are the common adverse reactions to MOXATAG?
Common adverse reactions include gastrointestinal disorders like diarrhea and infections such as vulvovaginal mycotic infection.
Is MOXATAG contraindicated in any patients?
Yes, MOXATAG is contraindicated in patients with known serious hypersensitivity to amoxicillin or other drugs in the same class, as well as those who have demonstrated anaphylactic reactions to beta-lactams.
Who currently promotes MOXATAG in the U.S.?
Vernalis Therapeutics, Inc. currently promotes MOXATAG in the U.S.
Sources
- MiddleBrook Pharmaceuticals, Inc. Says FDA Okays Strep Throat Drug, Shares Up. Biospace.
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. Drug Development.
- MOXATAG Label. FDA.
- MOXATAG Label. FDA.
- Vernalis PLC Begins Promotion Of MOXATAG (Amoxicillin Extended-Release) Tablets to Primary Care Physicians in the U.S.. Biospace.
