Antibiotic Approved for Acute Bacterial Sinusitis

Zithromax (azithromycin) by Pfizer Inc. was approved by the U.S. Food and Drug Administration on Jan. 20 as a once-daily, three-day treatment for acute bacterial sinusitis. Zithromax is the only antibiotic approved as a three-day treatment regimen for acute bacterial sinusitis, according to a company press release.

Most antibiotics commonly prescribed for acute bacterial sinusitis require seven to 14 days of multidose therapy, according to the release. Zithromax's unique attributes include high and sustained drug levels in infected tissues that make a shortened dosing regimen possible.

In one randomized, double-blind controlled study, Zithromax 500 mg once daily for three days was compared with another commonly used 10-day antibiotic regimen. Clinical efficacy for the three-day Zithromax regimen was comparable to the 10-day regimen of the other drug, according to the company.

Also, 99% of patients taking the three-day Zithromax regimen completed the course of therapy compared with 82% for the 10-day regimen. Patients taking Zithromax reported fewer side effects than did patients taking the other drug. The discontinuation rate due to adverse events was lower for Zithromax.

Drug Approved for Adults with Partial Seizures

The U.S. Food and Drug Administration granted approval for Lamictal (lamotrigine) by GlaxoSmithKline on Jan. 14 for use as monotherapy for treatment of partial seizures in patients 16 years and older when converting from the older antiepileptic drug, valproate.

The expanded indication is based on the results of an 18-week study of Lamictal and valproate. Seventy-seven patients with epilepsy were converted to monotherapy with Lamictal from valproate over the course of the study, according to a company press release. The study demonstrated that withdrawal to monotherapy with Lamictal from valproate can be achieved while maintaining consistent blood concentrations of Lamictal.

The most common adverse events in the study were dizziness (23%), nausea (16%), headache (14%), tremor (13%) and asthenia (12%). Of the 77 patients enrolled in the study, 21% withdrew because of adverse events.

The FDA has approved three new indications for Lamictal in the past 12 months, according to a company press release. In 2003, the FDA granted approval for Lamictal as adjunctive therapy for partial seizures in pediatric patients and as a maintenance treatment for bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with Lamictal use. The incidence of these rashes is about 0.8% in pediatric patients under the age of 16 receiving Lamictal as adjunctive therapy for epilepsy and 0.3% in adults receiving Lamictal for epilepsy. Rates of serious rash have been lower in trials for bipolar disorder, according to the company.

Combination Drug Approved for Bipolar Depression

Symbyax (olanzapine and fluoxetine) by Eli Lilly and Co. was approved by the U.S. Food and Drug Administration on Dec. 20, 2003, for the treatment of depressive episodes associated with bipolar disorder. Symbyax is a combination of the active ingredients found in Zyprexa (olanzapine) and Prozac (fluoxetine), and the company said in a press release that it is the first drug specifically approved for the treatment of bipolar depression.

According to a study published in the Archives of General Psychiatry in November 2003, Symbyax helped treat the symptoms of bipolar depression more effectively and at a significantly higher rate than did placebo. Over the eight-week study, Symbyax patients had no statistically greater risk of treatment-emergent mania than did patients taking placebo.

The most common adverse event reported in clinical trials in patients taking Symbyax was drowsiness. Other common events noticed were weight gain, increased appetite, weakness, swelling, tremor, sore throat and difficulty concentrating.

Zyprexa is indicated in the United States for the treatment of schizophrenia and the short-term treatment of acute manic episodes associated with bipolar disorder. Prozac is used for the treatment of depression, obsessive-compulsive disorder and bulimia.

Expanded Use Approved for Wakefulness Drug

Cephalon announced on Jan. 26 that the U.S. Food and Drug Administration had approved Provigil (modafinil) to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift-work sleep disorder (SWSD). Provigil has been indicated for the treatment of narcolepsy since 1998.

Provigil promotes wakefulness in preclinical studies without causing generalized stimulation in the brain, according to a company press release. The exact mechanism of action of Provigil is not known.

The safety of Provigil has been demonstrated in studies of more than 3,500 patients, according to the company. Provigil has been shown to have no effect on a person's ability to sleep when sleep is desired, according to the release.

Provigil is supplied in tablets of 100 mg and 200 mg. The recommended dose of Provigil is 200 mg once daily. Patients with narcolepsy and OSAHS should take Provigil as a single dose in the morning. Patients with SWSD should take Provigil about one hour before the beginning of their work shift.

Colorectal Cancer Drug Gets FDA Approval

Eloxatin (oxaliplatin for injection) by Sanofi Synthelabo has been approved by the U.S. Food and Drug Administration for the first-line treatment of advanced colorectal cancer. Eloxatin had been approved for second-line treatment of patients with metastatic carcinoma of the colon or rectum.