Drug Pipeline

New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer

New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia

For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.

In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.

After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.

A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).

Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.

New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.

Generic drugs approved by FDA (through January 2009) including rocuronium injection and budesonide inhalation suspension

Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.

Sugammadex is a novel, first-in-class, selective relaxant binding agent that encapsulates the nondepolarizing aminosteroid muscle relaxants rocuronium and vecuronium, reversing and preventing their neuromuscular block (NMB) action. Clinical trials have demonstrated that sugammadex is effective in reversing both rocuronium- and vecuronium-induced NMB, and the agent has been well tolerated in studies.

The Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."

FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).

FDA informed healthcare professionals that the agency is evaluating data regarding a potentially increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, in association with phenytoin (Dilantin, Pfizer; Phenytek, Mylan; generic phenytoin) or fosphenytoin (Cerebyx, Pfizer; generic fosphenytoin) treatment in Asian patients who are positive for the human leukocyte antigen allele HLA-B*1502.

Rosiglitazone was associated with an increased risk of all-cause mortality and congestive heart failure (CHF) compared with pioglitazone in an inception cohort study of patients aged >65 years. Patients treated with rosiglitazone or pioglitazone demonstrated similar rates of myocardial infarction (MI) and stroke. These results were published in the Archives of Internal Medicine.

Patients with chronic hepatitis C virus (HCV) infection who have not responded to previous treatment with pegylated interferon alfa-2a (peginterferon) and ribavirin do not demonstrate a reduced rate of disease progression when they undergo long-term treatment with pegylated interferon alfa-2a compared with untreated patients. These results were published in the New England Journal of Medicine.

Evidence supports the clinical equivalence of generic and brand-name cardiovascular drugs, according to a meta-analysis published in the Journal of the American Medical Association. Despite this evidence, more than half of the editorials discussing the issue of generic interchangeability that were assessed in this analysis do not support generic substitution for brand-name cardiovascular drugs.

New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder

Second-generation antidepressants generally have equivalent efficacy, according to a review published in the Annals of Internal Medicine. Although these agents demonstrate similar response rates, differences in onset of action or side effects may affect prescribing decisions.

Treatment with bevacizumab is associated with a significantly increased risk of venous thromboembolism, according to a meta-analysis published in the Journal of the American Medical Association.

During his campaign for the presidency, President-elect Barack Obama stated that all Americans have a right to healthcare and that he will expand coverage for the uninsured. Many voters cited healthcare as a key election issue; however, the need to address a rising unemployment rate and low economic growth may force Obama to seek more limited changes in the near future.

Among the new data presented at the 2008 AHA Scientific Sessions were the results of JUPITER, as well as a phase 2 study of rivaroxaban and an observational study of DES versus BMS in diabetics.

Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution

New biologic: C1 inhibitor (human) (Cinryze) was approved on October 10, 2008, for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema

New molecular entity: Lacosamide (Vimpat), an antiepileptic drug, was approved on October 28, 2008, as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years or older

New molecular entity: Silodosin (Rapaflo), an alpha-blocker, was approved on October 8, 2008, for the treatment of the signs and symptoms of BPH

In 2003, the Canadian Forces (CF) drug benefit plan used preferential listing to control costs associated with proton pump inhibitors (PPIs); however, significant expenditures for nonbenefit PPIs continued. A database review was thus conducted to explain this anomalous usage pattern. This study provides further information regarding the effectiveness of preferred listing as a cost-saving measure, noting that adherence to such policies may be less than projected.

On November 7, the First District Court of Appeal in San Francisco, California, overturned a previous ruling in the case of Conte v Wyeth and ruled that Wyeth, the manufacturer of Reglan (metoclopramide), should be held responsible for harm caused to Elizabeth Conte, who developed tardive dyskinesia after taking generic metoclopramide for nearly 4 years. The court upheld the previous ruling in favor of Purepac, Pliva, and Teva, manufacturers of generic metoclopramide.

In a large, population-based cohort study published in the Archives of Internal Medicine, current use of statins by patients hospitalized with pneumonia was associated with a decreased risk of death after hospital admission compared with nonusers of statins.

Compared with biguanides, thiazolidinediones, meglitinides, and second-generation sulfonylureas, metformin is the sole oral therapy associated with a decreased risk of cardiovascular (CV) mortality in patients with type 2 diabetes, according to a meta-analysis published in the Archives of Internal Medicine.