Drug Pipeline

Generic drugs approved by FDA (through April 2009) including malathion lotion, 0.5%

Clevidipine is an intravenous (IV) dihydropyridine calcium-channel blocker (CCB) that is approved for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable. Clevidipine is effective at reducing BP in the emergency room (ER), intensive care unit (ICU), and in the pre-, peri-, and postoperative settings.

New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD

A retrospective cohort study published in the Journal of the American Medical Association demonstrated that concomitant use of clopidogrel and a proton-pump inhibitor (PPI) after hospital discharge for acute coronary syndrome (ACS) is associated with an increased risk of all-cause mortality and rehospitalization for ACS.

Apparently healthy people with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein (hsCRP) demonstrated a significant relative reduction in stroke risk if treated with rosuvastatin rather than placebo in the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, according to data presented at the International Stroke Conference 2009.

Two-thirds of US hospitals do not administer tissue plasminogen activator (t-PA) to patients who have a stroke and are covered by Medicare, according to the results of a national study conducted between 2005 and 2007, which were presented at the International Stroke Conference 2009.

FDA has issued a public health advisory regarding a risk of burns during magnetic resonance imaging (MRI) scans in patients wearing transdermal medication patches that contain aluminum or other metals in the backing of the patches. The patches can overheat during the scan, leading to skin burns in the area of the patch.

FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.

Synta Pharmaceuticals and GlaxoSmithKline have announced that they are suspending a phase 3 trial of elesclomol in chemotherapy-naïve patients with stage IV metastatic melanoma because of safety concerns.

Catheter delivery of tissue plasminogen activator (t-PA) improves survival and functional outcomes at 6 months in patients with intraventricular hemorrhage (IVH), according to the final results from a phase 2b study known as Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR IVH).

OPKO Health announced that it is terminating a phase 3 trial of bevasiranib for the treatment of wet age-related macular degeneration (wet-AMD).

ViroPharma has announced that it is discontinuing a phase 3 trial of maribavir for prophylaxis against cytomegalovirus (CMV) disease in patients undergoing a liver transplant.

In a decision handed down March 4, 2009, the U.S. Supreme Court ruled in favor of Levine in the court case Wyeth v Levine, upholding the ruling of the Vermont Supreme Court. This decision may set a precedent for rejecting the argument of pre-emption, a tenet holding that FDA regulations connected with drug approvals and medication safety supersede state laws.

In a study published in the Journal of the American Medical Association, investigators demonstrated an association between treatment with the anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies (mAbs) adalimumab and infliximab and risk of herpes zoster events in patients with rheumatoid arthritis (RA).

In a retrospective cohort study published in the Archives of Internal Medicine, higher continuity of statin treatment was associated with a lower risk of all-cause mortality among patients with or without coronary heart disease (CHD).

A prominent theme in health-reform efforts is the need for more transparent information about healthcare cost and quality upon which providers and patients can base their treatment decisions. Many federal agencies and state governments are expanding their requirements for pharmaceutical companies to report payments made to researchers and physicians, and for health plans to give beneficiaries more information on drug costs and coverage.

Although there have been significant advances in prevention, diagnosis, treatment, and education, the occurrence of sexually transmitted diseases (STDs) continues to increase. This article focuses on the diagnosis and treatment of the most common STDs.

Generic drugs approved by FDA (through March 2009) including sumatriptan tablets, divalproex extended-release tablets, and risperidone oral solution

Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.

New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis

New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients

Febuxostat (Uloric): Xanthine oxidase inhibitor approved for chronic management of hyperuricemia in patients with gout

At a joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees on January 30, 2009, advisors voted 14 to 12 that propoxyphene and propoxyphene-containing products should be removed from the market. Propoxyphene (Darvon, Xanodyne; generic propoxyphene) and propoxyphene combinations, including Darvocet (Xanodyne), are used for the treatment of mild-to-moderate acute pain.

In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.

Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.