Latebreakers: November 6, 2006

Standards group endorses MTM by R.Ph.s

Pharmacists should actively participate in medication therapy management systems. That's one of 30 safe practices the National Quality Forum (NQF) has just endorsed. Of the remaining safe practices, at least 10 are drug-related. They include calling for establishing a computerized prescriber order entry system and a list of abbreviations that should not be used. NQF is a voluntary consensus standard-setting organization whose goal is to improve the quality of health care.

Aricept now covers all degrees of dementia

Allergy nasal spray given OK

There is now a new corticosteroid available for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. Ciclesonide (Omnaris, Altana Pharma) nasal spray has received approval for the treatment of adults and children 12 years of age and older. In clinical trials leading to the approval, patients using ciclesonide had an 8% to 10% greater reduction in nasal symptoms compared with those using placebo. The most common adverse effects were headache, inflammation of the nose and throat linings, and nosebleeds.

New approval for head and neck cancer

Following priority review of a supplemental NDA, Sanofi-Aventis has received regulatory approval to begin marketing docetaxel (Taxotere) Injection Concentrate to be used in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. Patients receiving the docetaxel-containing regimen prior to radiation had longer overall survival compared with patients receiving cisplatin and fluorouracil alone (18.6 months vs. 14.2 months), with a 29% risk reduction of death. Docetaxel was previously approved for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, and gastric cancer.

Expanded indication for UC therapy

Infliximab (Remicade, Centocor) has received yet another approval from the FDA. This time an expanded indication has been granted for maintaining clinical remission and mucosal healing in patients with moderate to severe ulcerative colitis (UC) who have not responded well to conventional treatment. The biologic was initially approved as a therapy for UC in September 2005. This most recent approval was based on the ACT 1 trial, which found that 35% of patients taking infliximab were in clinical remission at week 54 compared with 17% in the placebo group. Infliximab received its first approval in 1998 for the treatment of Crohn's disease.

First DPP-4 inhibitor gets FDA nod

The first and long-awaited dipeptidyl peptidase-4 (DPP-4) inhibitor will soon make its debut. Januvia (sitagliptin, Merck) has been approved as monotherapy and as an add-on therapy to either metformin or a thiazolidinedione to improve glycemic control in Type 2 diabetes patients. The drug works by inhibiting the action of DPP-4 and increasing levels of incretin hormones GIP and GLP-1, which not only increase insulin synthesis and release from the pancreas but also lead to reduced hepatic glucose production. Sitagliptin is not indicated for patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis. Results from a 24-week trial of sitagliptin 100 mg daily versus placebo showed a reduction in A1c levels of 0.7% in patients with moderately elevated levels at baseline.