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.
Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)
Approvable designations
FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.
Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine
A review of agents in late-stage development for the treatment of depression (July 2006).
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.
A review of agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006).
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.
A cross-sectional study of the agendas and transcripts of FDA drug advisory committee meetings from 2001 to 2004 found that conflict of interest disclosures occurred at 73% of the meetings examined, but that the recusal of advisory committee members from decision-making as a result of those conflicts occurred only 1% of the time.
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.
Human papillomavirus (HPV) (types 6, 11, 16, 18) vaccine (Gardasil, Merck) for female patients aged 9 years or older
Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.
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 review of selected antibiotics in late-stage development (May 2006).
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.
