New Drug Treats IBS with Constipation
The FDA approved lubiprostone (Amitiza) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women 18 years of age and older. Lubiprostone is the first FDA-approved medical treatment for IBS-C in the United States. Lubiprostone was previously approved for treatment of chronic idiopathic constipation.
Safety and efficacy of lubiprostone were shown in two major placebo-controlled studies of 1,154 patients with IBS-C, the majority of who were women. More patients treated with lubiprostone reported that their IBS symptoms were moderately or significantly relieved over a 12-week treatment period than patients who were given placebo. Long-term safety studies were conducted for 9 to 13 months. The efficacy of lubiprostone in men was not conclusively demonstrated for IBS-C.
Lubiprostone is taken twice daily with food and water. Common side effects of treatment include nausea, diarrhea, and abdominal pain. Rare side effects include urinary tract infections, dry mouth, syncope, peripheral edema, dyspnea, and heart palpitations. The drug is not approved for use in children or men.
Nasal Spray Relieves Seasonal Allergic Rhinitis
Alcon's olopatadine (Patanase) nasal spray has been approved for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
Clinical studies of olopatadine in patients with seasonal allergic rhinitis showed that those who used olopatadine (two sprays per nostril, twice daily) got relief from allergy symptoms. Assessment was based on total nasal symptom scores (TNSS) (a composite of nasal congestion, rhinorrhea, itchy nose, and sneezing). Patients who used olopatadine had significantly greater decreases in TNSS compared with those taking placebo nasal sprays.
Studies showed olopatadine's onset of action was 30 minutes, with a 12-hour duration of effect after dosing-which were statistically significant compared with the placebo spray.
The most common side effects associated with the use of olopatadine include bitter taste, headache, epistaxis, pharyngolaryngeal pain, postnasal drip, cough, and urinary tract infection.
Combination Triptan-NSAID Targets Migraines
GlaxoSmithKline's sumatriptan 85 mg/naproxen sodium 500 mg (Treximet) was approved for the acute treatment of migraine attacks with or without aura in adults. Treximet is a migraine product that targets multiple mechanisms of migraine by combining a triptan and an anti-inflammatory pain reliever in a single tablet.
In clinical trials, Treximet provided a greater percentage of patients with migraine relief at 2 hours compared with sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, patients treated with a single dose of the combination product were more likely to remain pain free without use of rescue medications through 24 hours postdose compared with those receiving sumatriptan, naproxen, or placebo. The combination also decreased migraine symptoms such as photophobia, phonophobia, and nausea.
Treximet was generally well tolerated in clinical studies. Most adverse events were mild and transient in nature, including dizziness, somnolence, nausea, chest discomfort/pain, and neck/throat/jaw pain/tightness/pressure.
New Risedronate Tablets Approved
A new once-a-month 150-mg dose of risedronate (Actonel) has been approved for the treatment and prevention of postmenopausal osteoporosis. Risedronate is approved to reduce the risk of fractures in postmenopausal women with osteoporosis.
The FDA approval was based on a study comparing 150 mg risedronate once monthly with 5 mg risedronate daily. Similar increases in bone mineral density were seen among patients taking either once-monthly or daily dosing regimens.