Drug Pipeline

In patients with chronic low back pain with comorbidities such as hypertension, diabetes, and cardiovascular disease, extended-release oxymorphone (Opana ER, Endo Pharmaceuticals) may be a safe and effective alternative, according to a study presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

No new or unexpected safety issues occurred during long-term treatment with a fixed-dose combination of naproxen and esomeprazole magnesium (Vimovo) in patients at risk of NSAID-associated upper gastrointestinal ulcers, according to data presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Hemoglobin A1c levels below 6% are associated with a small but significant increased risk of mortality in elderly patients, according to a retrospective cohort study published online in Diabetes Care.

FDA approved the use of meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) in children aged as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.

FDA approved linagliptin (Tradjenta, Boehringer Ingelheim and Eli Lilly) tablets, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.

The effectiveness and safety of proton pump inhibitors for pediatric gastroesophageal reflux disease are far from proven, according to a new systematic review.

Systemic lupus erythematosus is a multi-organ, autoimmune inflammatory disease. The annual incidence of SLE in the United States ranges from 2.0 to 7.6 cases per 100,000 persons per year. This review examines the clinical course of SLE, various treatment options, and the treatment of specific manifestations of the disease such as lupus nephritis.

The FDA has released a safety communication alerting healthcare providers to a new risk evaluation and mitigation strategy for ipilimumab.

Recent FDA Approvals (through April 2011) related to Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant

Drug devleopment pipelines have shrunk; fewer new products are being approved for market; and pharma companies are scaling back R&D as patent expirations on blockbuster drugs reduce industry revenues.

Recent FDA action (through April 2011) related to Liprotamase, Aricept Patch, Telaprevir, Restylane Injectable Gel, VEGF Trap-Eye, Cenderitide, PV-10, INNO-206

A new selective estrogen receptor modulator, bazedoxifene acetate, is currently under development in an effort to maximize potential benefits on bone, lipids and breast tissue while minimizing endometrial hyperplasia and other adverse effects.

The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis.

New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.

Alcoholics who are tested for genotype specificity prior to receiving ondansetron may have significantly improved outcomes, according to new research.

Analysis of the hepatitis C virus kinetics during treatment with protease inhibitor telaprevir shows a rapid decline, according to a new study.

Generic drug approved by FDA (through May 2011): Latanoprost

New molecular entity: Azilsartan medoxomil tablets are selective AT1 subtype angiotensin receptor antagonists that were approved by FDA to lower blood pressure.

FDA has approved abiraterone acetate (Zytiga, Centocor Ortho Biotech), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Adding twice-daily exenatide injections to (basal) insulin glargine improved glycemic control without increasing the risk for hypoglycemia or weight gain in patients with uncontrolled type 2 diabetes, according to a randomized and placebo-controlled trial.

This month, FDA launched its revamped Recalls, Market Withdrawals, and Safety Alerts website, making it easier for consumers to search and view food and product recall information going back to 2009.

Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology.

Dalteparin was not better than unfractionated heparin for the prevention of deep vein thrombosis among critically ill patients, according to an international study published in the New England Journal of Medicine.

The Obama administration recently unveiled a multiagency plan to reduce the ?epidemic? of prescription drug abuse in the United States. It will include an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients.

Transdermal buprenorphine (Butrans Transdermal System, Purdue Pharma) was superior to placebo in treating opioid-naïve patients with moderate-to-severe chronic low back pain, according to study results presented at the annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.

One 30-minute application of a capsaicin (8%) patch (NGX-4010, Qutenza, NeurogesX) can reduce neuropathic pain due to HIV-associated neuropathy, according to data presented here at the annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.

Conversion to a 7-day regimen of transdermal buprenorphine (Butrans Transdermal System, Purdue Pharma) from a stable regimen of hydrocodone/acetaminophen (Vicodin, Abbott) can be successful in patients with osteoarthritic pain of the hip or knee, according to a study presented at the annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.

Topical diclofenac is safer and better tolerated by patients with osteoarthritis of the knee compared with the oral formulation, according to data presented here at annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.