Drug Pipeline

Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev

FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.

FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.

A look at the therapeutic pipeline for glaucoma shows several medications representing new pharmacologic classes are currently being evaluated in clinical trials, said John R. Samples, MD, at ASCRS Glaucoma Day 2011, San Diego.

A newly developed assay can measure the ability of antibiotics to associate with mammalian cells and protect the cells from bacterial destruction. Of 4 antibiotics tested in this assay, the data showed a range of therapeutic effectiveness in 2 cell lines that clinicians can consider when establishing dosing regimens, according to Jeremy Wingard, MD, who reported his group's findings at the American Society of Cataract and Refractive Surgery annual meeting, San Diego.

Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.

At a fixed dose of 12 mg, methylnaltrexone bromide (Relistor, Progenics Pharmaceuticals) subcutaneous injection proved generally safe and well tolerated in non-malignant pain patients with opioid-induced constipation, according to a recent study.

First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.

Medication use among pregnant women is widespread and increasing, according to a recent study from the Boston University School of Public Health in Boston.

FDA has approved sunitinib malate (Sutent, Pfizer) as the first anti-vascular endothelial growth factor therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Vardenafil HCI (Staxyn, GlaxoSmithKline, Merck, and Bayer), an orally disintegrating tablet indicated for the treatment of erectile dysfunction in men, is now available in U.S. pharmacies.

NEW YORK (Reuters Health) - For patients with type 2 diabetes not controlled with metformin and a sulfonylurea, the choice of an additional agent should be based on individual clinical characteristics since improvements in glucose control are similar.

FDA approved telaprevir (Incivek, Vertex) tablets to treat certain adults with chronic hepatitis C infection.

FDA has approved rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy.

Proton pump inhibitors are associated with a 29% increased risk of fracture, including a 31% increased risk of hip fracture and a 54% increased risk of vertebral fracture, according to a study published in the May/June 2011 issue of Annals of Family Medicine.

More than half of Medicare claims for atypical antipsychotic drugs are erroneous, amounting to $116 million, according to a 48-page report released May 4 by the Office of the Inspector General.

Pediatric patients with moderately to severely active ulcerative colitis demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.

There is no safe therapeutic window of time for using NSAIDs in patients with prior myocardial infarction. Even short-term treatment with most NSAIDs appears associated with increased risk of death and recurrent MI. In general, NSAIDs should be limited from a cardiovascular safety point of view, according to a study published in Circulation.

FDA has approved boceprevir (Victrelis, Merck) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients aged 18 years and older with compensated liver disease.

LOS ANGELES (Reuters) - Ariad Pharmaceuticals' experimental cancer drug may improve overall survival in patients with advanced sarcoma, according to data from a phase III trial released Wednesday.

NEW YORK (Reuters) - A drug from Pfizer Inc delayed progression of advanced kidney cancer by nearly seven months, and by two months longer than a commonly used medicine, in previously treated patients, according to data from a late stage clinical trial.

Adult patients with schizophrenia treated with lurasidone HCl tablets (Latuda, Sunovion Pharmaceuticals) had minimal weight gain and metabolic changes, according to the results from a new pooled data analysis of short- and long-term studies, which were presented at the Annual Meeting of the American Psychiatric Association in Honolulu, Hawaii.

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.

Denosumab (Xgeva, Amgen) significantly increased bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that had not yet spread to bone, according to results of a landmark study of Xgeva, presented at a late-breaking plenary session at the American Urological Association?s 2011 annual meeting in Washington, DC.

FDA has approved everolimus (Afinitor, Novartis) tablets to treat patients with progressive neuroendocrine tumors of pancreatic origin that cannot be removed by surgery or that have spread to other parts of the body.