Drug Pipeline

Generic drugs approved by FDA (through June 2010): Venlafaxine hydrochloride extended-release capsules, Meropenem for injection, Adapalene 0.1% gel, Aztreonam for injection, Oxaliplatin for injection

On June 11, 2010, FDA announced in a drug safety communication that the agency was currently evaluating whether the use of the angiotensin II receptor blocker olmesartan (Benicar, Daiichi Sankyo) (also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.

Transparency has become the lead philosophy governing biomedical research and regulation. FDA and the National Institutes of Health are requiring more disclosure of financial relationships between industry and scientists and physicians.

A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.

New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

A recent landmark phase 3 trial in patients in remission from recurrent hepatic encephalopathy demonstrated that rifaximin at a dose of 550 mg twice daily is significantly more effective than placebo in maintaining remission and reducing the risk of hospitalization. Rifaximin's approval by FDA in March 2010, offers clinicians the first pharmacologic treatment for hepatic encephalopathy in more than 30 years.

In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.

A systematic review and meta-analysis evaluating the effects of rosiglitazone on cardiovascular morbidity and mortality confirmed the finding of increased odds of myocardial infarction with rosiglitazone.

Hemophilia is a rare congenital bleeding disorder, resulting from a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B). Deficiency of either of these factors interrupts normal hemostasis resulting in an inability to form a stable fibrin clot to halt bleeding. This article reviews the etiology of hemophilia, available pharmacologic approaches to bleeding episodes, and treatment options in the presence of complications.

Labeling for all prescription and over-the-counter proton pump inhibitors will have to include wording about a possible increased risk of hip, wrist, and/or spine fractures with their use.

FDA notified providers and patients that they are continuing to review available data suggesting an increase in the risk of diabetes, heart attack, stroke, and sudden death in men treated with gonadotropin-releasing hormone agonists as androgen deprivation therapy for prostate cancer.

FDA appears to be requesting some kind of Risk Evaluation and Mitigation Strategy on most new drug products.

Pulmonary arterial hypertension (PAH) is a rare but progressive condition characterized by abnormal proliferation and remodeling, vasoconstriction, and thrombosis of the pulmonary vasculature, leading to elevated pulmonary arterial pressure, increases in peripheral vascular resistance, and ultimately to right heart failure and death. Recently, the therapeutic armamentarium for PAH has expanded.

Obesity is a prevalent disease that has reached epidemic proportions in both the developed and developing world. In the United States, it is estimated that 66% of the adult population is overweight or obese. There are several available pharmacologic treatments for obesity used as an adjunct to diet, exercise, and behavioral therapy. However, weight loss with these agents is modest and usually reversible when the drug is discontinued, and novel, more-effective anti-obesity agents are desperately needed.

Recent FDA Approvals (through May 2010) related to Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix

New Molecular Entity: Estradiol valerate/dienogest (Natazia) was approved in May 2010 for the prevention of pregnancy.

Recent FDA action (through, May 2010) related to BMS-224818, Roflumilast, Prostvac, Naltrexone, IL13-PE38QQR/IL13-PE, Prochymal, AEZS-108, SBC-102, Pralatrexate, RG2833

According to the Academy of Managed Care Pharmacy (AMCP) and software partner Dymaxium Healthcare Innovations, the AMCP eDossier System is catching on among decision makers and drug companies alike.

New Formulation: Miconazole buccal tablets (Oravig) was approved in April 2010 for the local treatment of oropharyngeal candidiasis in adults.

Low-dose oral colchicine is just as effective as high-dose colchicine in reducing pain associated with early acute gout flare, but with a safety profile statistically indistinguishable from placebo, according to a study published in the April issue of Arthritis & Rheumatism, the official journal of the American College of Rheumatology.

Anticonvulsant agents have important therapeutic benefits. However, both the healthcare provider and patient need to remain cognizant of associated risks, according to results of a study published in the April 13, 2010, edition of the Journal of the American Medical Association.

The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), announced the winners in the 10th Annual AMCP/FMCP National Student Pharmacist Pharmacy & Therapeutics (P&T) Competition, and FMCP Best Student Pharmacist and Best Resident or Fellow Poster Contests.

Patients with coronary heart disease (CHD) or CHD equivalent on stable statin monotherapy treated with the addition of extended-release niacin have significant decreases in carotid intima-media thickness compared with those who had ezetimibe added to their stable statin treatment, according to a study published online April 14 in the Journal of the American College of Cardiology, as reported by HealthDay News.

Of 10 antiepileptic drugs (AEDs) studied in older adults with epilepsy, lamotrigine closely followed by levetiracetam is the most effective, as measured by 12-month retention and freedom from seizures, while oxcarbazepine is consistently less effective than other AEDs, according to research published in the April issue of the Archives of Neurology, as reported by HealthDay News.

In older patients treated with warfarin, the use of cotrimoxazole is associated with a higher risk of upper gastrointestinal tract hemorrhage than other common antibiotics, according to research published in the April 12 issue of the Archives of Internal Medicine, as reported by HealthDay News.

Liraglutide offered superior glycemic control to sitagliptin in patients with type 2 diabetes who had inadequate glycemic control on metformin, according to a recent report in The Lancet.

Since Congress passed healthcare reform legislation in March, Formulary has continued to ask for your feedback. Here is your response.

Despite known contamination with porcine circovirus type 1, an FDA advisory panel recently agreed that Rotarix (GlaxoSmithKline) and RotaTeq (Merck), two approved vaccines to prevent rotavirus infection, should continue to be used.

FDA Amendments Act of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.

On March 10, 2010, FDA announced that its review of data requested in June 2008 from all bisphosphonate drug manufacturers did not suggest an increased risk of subtrochanteric femur fractures (bone breaks just below the hip) in those receiving oral bisphosphonates.