MiddleBrook Pharmaceuticals, Inc has launched Moxatag (extended-release amoxicillin) tablets, 775 mg, the first and only FDA-approved once-daily amoxicillin.

Moxatag is approved for the treatment of pharyngitis/tonsillitis secondary to Streptococcus pyogenes in patients twelve years and older. Moxatag is dosed once-daily at 775 mg, versus the current most commonly prescribed generic amoxicillin treatment regimen for pharyngitis/tonsillitis which is 500 mg three times per day according to the 2008 IMS Health National Drug Therapeutic Index. There is no AB-rated generic for Moxatag.

Moxatag is the first product formulated with MiddleBrook's proprietary Pulsys technology. Pulsys enables the pulsatile delivery, or delivery in rapid bursts, of amoxicillin from Moxatag. MiddleBrook's Pulsys technology prolongs the release and absorption of amoxicillin from Moxatag.

"Moxatag's once-daily dosing advances traditional treatment with amoxicillin, a drug that has been trusted and relied upon for the treatment of pharyngitis and tonsillitis for decades," said MiddleBrook president & CEO John Thievon. "Moxatag is effective, and Moxatag uses a lower overall dose than conventional amoxicillin or penicillin treatments for pharyngitis and tonsillitis."

"Studies show that enhanced patient convenience improves compliance," Thievon continued, "and we believe that compliance is a critical success factor in antibiotic therapy. In fact, studies show that failure to take antibiotics properly is the number one reason patients fail antibiotic therapy. Accordingly, Moxatag has the potential to help improve clinical outcomes. Our 271-person field force today began educating healthcare professionals across the nation about the benefits of Moxatag. We are excited about Moxatag's commercial potential."

MiddleBrook Pharma is a pharmaceutical company focused on developing and commercializing anti-infective products that fulfil unmet medical needs.

Moxatag (amoxicillin extended-release) tablets, 775mg, is a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release component and two delayed-release components.