Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.

Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of moderately to severely active Crohn’s disease in adults who have had an inadequate response to conventional therapy. Infliximab is also FDA-approved for the same indication in children ≥6 years old and for treatment of fistulas in adults. All 3 TNF inhibitors have been shown to reduce the signs and symptoms of Crohn's disease in clinical trials. They have been associated with adverse effects such as...

The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in patients with moderate to severe ulcerative colitis who do not respond to or cannot tolerate other therapies or who require continuous treatment with corticosteroids. Golimumab was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is the third TNF inhibitor to be approved for use in ulcerative colitis.

The FDA has approved lubiprostone (Amitiza - Sucampo/Takeda), a chloride channel activator, for treatment of chronic idiopathic constipation in adults. The only other prescription drug approved by the FDA for this indication (in 2004 for adults <= 65 years old) is tegaserod (Zelnorm), a partial agonist of serotonin that is also approved for constipation-predominant irritable bowel syndrome in women. Of course, numerous over-the-counter products are available for treatment of constipation.

Omeprazole (Losec - Merck), a new drug that suppresses gastric acid secretion, has been approved by the US Food and Drug Administration for short-term (four to eight weeks) treatment of severe or refractory gastroesophageal reflux and for long-term treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis. Although widely used abroad for treatment of peptic ulcers, it has not been approved for that indication in the USA.

An IV formulation of pantoprazole sodium (Protonix IV - Wyeth-Ayerst), a benzimidazole proton pump inhibitor (PPI), has been approved by the FDA for short-term treatment of Zollinger-Ellison Syndrome (ZES) and gastroesophageal reflux disease (GERD) in patients who cannot take oral drugs. Pantoprazole is the first PPI to be approved for IV use in the US.

Options in screening for colon cancer include fecal occult blood tests, flexible sigmoidoscopy, colonoscopy, computed tomography (CT) colonography and fecal DNA tests. Since the last Medical Letter article on this subject, more data have become available on colonography.

Olsalazine sodium (Dipentum - Pharmacia), a dimer (two molecules linked by an azo bond) of 5-aminosalicylic acid, was recently approved by the US Food and Drug Administration for oral use to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine (Azulfidine; and others).

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to be approved for use in combination with peginterferon and ribavirin for treatment of chronic HCV genotype 1 infection in adults with compensated liver disease. Telaprevir (Incivek) and boceprevir (Victrelis) were approved in 2011 for the same indication. Sofosbuvir (Sovaldi – Gilead), a nucleotide analog polymerase inhibitor that has been approved for use with and without interferon for treatment of multiple HCV...