Asmanex Twisthaler, Moxatag.

Asmanex Twisthaler (mometasone furoate inhalation powder, Schering-Plough Corp.)

The Food and Drug Administration approved Asmanex Twisthaler for once-daily maintenance treatment of asthma in children aged 4-11 years. The agency initially approved this agent for patients aged 12 years and older in March 2005.

* Special Considerations: Advise patients to rinse their mouths after inhalation of this agent; localized oral infections were reported by 195 (6.5%) of 3,007 patients in clinical trials. Use with caution in immunocompromised patients, including those with latent or active tuberculosis; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. The leading adverse reactions reported by 2% or more of 98 children aged 4-11 years in a 12-week clinical trial were fever, allergic rhinitis, abdominal pain, and vomiting. The Asmanex Twisthaler is not indicated for treatment of acute asthma episodes.

* Comment: Safety is based on a 52-week trial with 152 children. Efficacy is based on three 12-week clinical trials with 630 children aged 4-11 years. In one study, there was a significant improvement in mean forced expiratory volume in 1 second among 98 children treated with the Asmanex Twisthaler, compared with 99 using a placebo for 12 weeks. The other two trials likewise support the efficacy of the product, according to its labeling.

"It's significant to have other asthma medications in the armamentarium. [Asmanex Twisthaler] seems to have very good efficacy in adults and it's a great medicine for children," Dr. Jonathan Field said in an interview.

"It's a simple device with a built-in cap. It is fairly easy to use--usually one time per day--with a built-in dose counter." The dose counter allows physicians and parents to monitor compliance.

"Studies have shown less bioavailability compared to some other corticosteroids, so there is less concern about growth inhibition and HPA axis suppression," said Dr. Field, director of the Allergy and Asthma Clinic at New York University Medical Center-Bellevue Hospital, New York.

Research also indicates the agent is effective as monotherapy, whereas other asthma medications require use in combination with a long-acting [beta]-agonist, Dr. Field said. He has no disclosures regarding the Asmanex Twisthaler or Schering-Plough.

Moxatag (amoxicillin extended-release tablets, MiddleBrook Pharmaceuticals Inc.)

The FDA also approved once-daffy Moxatag tablets 775 mg for treatment of patients aged 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes infection.

* Recommended Dosage: One 775-mg tablet daily, taken within 1 hour of finishing a meal, for 10 days.

* Special Considerations: Moxatag is contraindicated in patients with known hypersensitivity to amoxicillin or other penicillin agents; serious anaphylactic reactions are possible. Treatment-related or probably treatment-related adverse events reported in a phase III trial of Moxatag included vulvovaginal mycotic infections, diarrhea, nausea, vomiting, abdominal pain, and headache.

* Comment: Safety and efficacy are based on a clinical trial of 302 adult and adolescent patients aged 12 years and older treated with Moxatag 775 mg once daily for 10 days. Researchers also included 306 adults and adolescents aged 12 years and older treated with penicillin VK 250 mg four times daily for 10 days.

Moxatag was "noninferior" to penicillin VK in terms of bacterial eradication of S. pyogenes in patients with positive throat cultures and symptoms of pharyngitis and/or tonsillitis. According to a modified intent-to-treat analysis, 79.7% of Moxatag-treated patients and 78.0% of the penicillin VK-treated group achieved bacterial eradication by day 4 to day 8 of the study.

"This approval is more significant for the company and not as significant in terms of meeting an urgent medical need," said Dr. Bruce Polsky, vice chairman of medicine and chief of the division of infectious diseases, St. Luke's-Roosevelt Hospital Center, New York.

Dr. Polsky questioned the indication for use in patients aged 12 years and older as strep throat is not common in the adult population. "Yes, it's convenient if someone wants to use a once-a-day version of amoxicillin. It's perfectly fine," he said.

Dr. Polsky has no financial disclosure regarding Moxatag or MiddleBrook Pharmaceuticals

BY DAMIAN McNAMARA, MIAMI BUREAU