Drug Pipeline

The anticonvulsant lacosamide is effective in relieving diabetic neuropathy and produces increased pain reduction with continued treatment for 22 months, according to phase 3 study results presented during the 25th Annual Scientific Meeting of APS in San Antonio, Texas. "This is a promising treatment that maintains a long-term effect," said Tibor Hidvegi, MD, Medical Department, Petz Hospital, Gyor, Hungary.

Morphine extended-release once daily significantly reduced pain among patients with chronic, moderate-to-severe low back pain compared with oxycodone controlled-release twice daily, according to results of a study presented at the 25th Annual Scientific Meeting of the American Pain Society (APS) in San Antonio, Texas. The once-daily opioid also demonstrated significant improvement in sleep scores, said Richard L. Rauck, MD, Carolinas Pain Institute, Winston-Salem, NC.

Valsartan is associated with a reduction in the levels of high-sensitivity C-reactive protein (hs-CRP), the inflammatory marker that is highly predictive of adverse cardiovascular outcomes, independent of its blood pressure-lowering effect, said Paul M. Ridker, MD, MPH, lead investigator of a trial presented at the 21st annual meeting of ASH.

The investigative agent aliskiren, the first orally active renin inhibitor, is an effective antihypertensive agent as monotherapy and in combination with hydrochlorothiazide, reported investigators at the 21st annual scientific meeting of ASH.

Phase 3 clinical trials demonstrated that the once-daily, highly selective beta blocker nebivolol lowers blood pressure in a dose-dependent manner and is well tolerated at all doses, according to presenters at the 21st annual scientific meeting of the American Society of Hypertension (ASH), in New York, NY.

FDA has announced further steps it plans to take to target the sales of counterfeit medications. The agency also rolled out a joint campaign with the Institute of Safe Medication Practices (ISMP) to discourage the use of confusing abbreviations that can potentially cause medication errors.

Diuretics are superior to both calcium channel blockers (CCBs) and, at least in the short term, angiotensin-converting enzyme (ACE) inhibitors in preventing heart failure (HF) in hypertensive patients, according to a follow-up analysis of the largest clinical trial on hypertension to date.

Investigators conducting a population-based, nested case-control study observed an association between the daily dose level of selective serotonin reuptake inhibitors (SSRIs) and a decreased risk of colorectal cancer among patients aged 5 to 85 years old. No consistent association was found between colorectal cancer risk and the use of tricyclic antidepressants (TCAs).

A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.

In 2001, off-label drug prescriptions accounted for 150 million (21%) of the estimated 725 million prescriptions written in the United States, according to the 2001 IMS Health National Disease and Therapeutic Index (NDTI). However, according to a study published in the Archives of Internal Medicine, 73% of the off-label medication prescriptions the authors researched (95% CI, 61%–84%) had little or no scientific backing.

Focused on a diverse number of areas in the study of gastrointestinal health, Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, yielded important information about the pharmacologic treatment of certain GI cancers and Crohn's disease.

A number of clinical approaches are utilized in managing insomnia. Indiplon (Pfizer) is a selective non-benzodiazepine sedative hypnotic under consideration by FDA for the treatment of insomnia. Like other agents in its class, indiplon binds selectively to the GABA-A receptors in the brain, promoting sleep.

Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

The activity of varenicline in the aiding of smoking cessation is believed to be the result of the agent's action at a sub-type of the nicotinic receptor where it acts as an agonist while simultaneously preventing nicotine binding to alpha 4 beta 2 receptors. Varenicline was approved on May 10, 2006, as an aid to smoking cessation treatment.

Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.

The blockbuster drugs of the 1990s came off-patent, became generic, and now several of them have become available OTC. Others are expected to join the ranks in the next few years.

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.

CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.

A phase 3 study evaluating the histologic and virologic improvement of hepatitis B antigen positive (HBeAg) patients randomized to either lamivudine or entecavir demonstrated that patients treated with entecavir had a significantly higher rate of histologic, virologic, and biochemical improvement. Researchers also observed less viral resistance with entecavir.

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) play a role in the treatment of hypertension (HTN) and heart failure (HF). The literature shows that in patients with HTN with comorbidities, such as HF, myocardial infarction (MI), diabetes mellitus, chronic kidney disease, and stroke, ACE inhibitors and ARBs appear to provide added benefit beyond solely lowering blood pressure. In addition, clinical trials have also demonstrated that ACE inhibitors and ARBs may be beneficial in the prevention of diabetes, atrial fibrillation (AF), and recurrent stroke. This review evaluates the practice guidelines and current literature to assess the implications for the use of ACE inhibitors or ARBs in HTN and HF.

A meta-analysis of 9 randomized, placebo-controlled studies of rheumatoid arthritis (RA) patients treated with the anti-tumor necrosis factor (anti-TNF) agents infliximab and adalimumab suggests an increased risk of malignancies dependent on dose and an increased risk of serious infections.

Varenicline (Chantix, Pfizer) is a partial nicotine receptor agonist with a high affinity for the alpha-4 beta-2 nicotinic acetylcholine receptors, modulating dopamine levels associated with nicotine addiction and aiding in smoking cessation. Clinical studies have demonstrated favorable cessation rates compared with placebo and sustained-release bupropion, with an encouraging safety profile. The most common adverse effect seen in clinical trials was mild-to-moderate nausea. In November 2005, a New Drug Application (NDA) was submitted for varenicline, and the drug was subsequently granted a 6-month priority review. On May 10, 2006, varenicline became the first oral medication approved for smoking cessation since bupropion, representing an agent with a novel mechanism of action for smoking cessation.

Rasagiline is an irreversible monoamine oxidase (MAO) inhibitor that is thought to exert its effect by specifically inhibiting MAO-B, thereby causing an increase in the extracellular levels of dopamine in the striatum.

Terconazole vaginal supposit-ories 80 mg (equiv to Terazol 3 vaginal suppositories)

A Kaiser Family Foundation study examined formularies, drug costs, and utilization management tools in drug plans offered by 14 national and near-national organizations, which encompass 35 unique prescription drug plans that account for 1,222 of the 1,429 packages available to Medicare beneficiaries.

As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.

In response to ongoing industry and beneficiary concerns about the Medicare Prescription Drug Plan, the Centers for Medicare and Medicaid Services (CMS) is clarifying the rules and reviewing the formularies of insurers who are applying to provide Part D coverage for next year. CMS is simultaneously crafting guidance and procedural improvements that aim to make the program operate more smoothly.

An analysis of data gathered from the National Hospital Discharge Survey (NHDS) shows that Clostridium difficile-associated disease (CDAD) rapidly increased among patients at US hospitals from 2000 to 2003, particularly among patients aged ?65 years.