Drug Pipeline

Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay

New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.

PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.

Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex

Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.

Intense public scrutiny of drug safety issues is prompting FDA to take a closer look at its program for establishing Risk Evaluation and Mitigation Strategies. Healthcare providers, as well as pharmaceutical companies, believe that the program is being overused, raising costs, and interfering with patient treatment.

A new case-control study nested within a large database of human immunodeficiency virus (HIV)-infected patients found abacavir initiation was associated with increased odds of having a myocardial infarction, while longer exposure to abacavir was not.

Platelet response to clopidogrel (Plavix) may be enhanced by concomitant use of agents that induce cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), according to research presented during the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.

New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia) was approved for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor.

Atrial fibrillation (AF) is the most common form of arrhythmia, affecting an estimated 2.2 million people in the United States. The goal of treatment is to reduce symptoms through rate or rhythm control and to prevent a cardioembolic event. Dronedarone (pronounced droe'' ne' da rone) is a noniodinated benzofuran derivative with characteristics of all 4 Vaughan-Williams antiarrhythmic classes. A search in clinicaltrials.gov for dronedarone phase 3 studies yielded 5 randomized controlled studies that investigated the efficacy and safety of the drug.

Recent FDA Approvals (through August/September 2010) related to Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz.

Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.

Non-Hodgkin's lymphoma (NHL) has several subtypes, with subtle variations, which leads to reduced effectiveness of standardized therapies. The introduction of rituximab, which targets B-cells, has had a positive effect on the management of NHL, but much still needs to be accomplished.

Pain is a significant medical problem and choosing the appropriate treatment may be complex. Opioids are considered a gold standard in the treatment of pain and as pain management has become a more prominent strategy, opioid dependence has become more frequent. The misuse and abuse of opioids have also increased. Successful management of opioid dependence requires utilization of both pharmacologic and nonpharmacologic treatment.

New combination: Dutasteride and tamsulosin (Jalyn) was approved by FDA for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa

Fingolimod is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS) and may represent a first-in-class sphingosine 1-phosphate receptor modulator as well as the first oral therapy for the treatment of RRMS.

Multiple sclerosis (MS) is a significant cause of disability among young adults, more commonly women, and usually strikes patients in the prime of their lives. Despite recent therapeutic advancements, MS remains an incurable, chronic illness. Clinical evidence supports the role of disease-modifying therapy early in the disease course to reduce the number of acute attacks, delay disease progression, maintain quality of life, and prevent disability.

In patients with low back pain of at least moderate severity and lasting for at least 6 weeks, a new 7-day buprenorphine transdermal system was found to provide better pain control, improve sleep quality, and health-related quality of life as compared with placebo.

New Formulation: Buprenorphine (Butrans) was approved in June for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.

On July 8, FDA released a "Drug Safety Communication" warning that off-label use of quinine sulfate (Qualaquin, AR Scientific) to treat night-time leg cramps has been found to result in serious and life-threatening adverse effects.

A systematic review and meta-analysis conducted by researchers at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, Cleveland, suggests that angiotensin-receptor blockers (ARBs) are associated with "a modestly increased risk" of developing cancer (RR increase of 8%, P=.016).

Generic drugs approved by FDA (through July 2010): Naratriptan hydrochloride tablets, Famotidine for oral suspension, Adapalene cream, Enoxaparin sodium injection, Oxymorphone hydrochloride

New Combination: Mometasone furoate and formoterol fumarate dihydrate (Dulera) was approved in June for the treatment of asthma in patients ?12 years of age.

Seven-day, transdermal buprenorphine patches are as effective as sublingual buprenorphine in the treatment of patients with osteoarthritis pain, according to a randomized, double-blind clinical trial recently published on-line ahead of print in the Journal of Pain and Symptom Management.

A number of high-profile drug and biotech manufacturing breakdowns in recent months is raising questions about industry investment in, and commitment to, modern production systems able to meet FDA standards.

New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.

Forty-two cases of progressive multifocal leukoencephalopathy (PML) in patients receiving the humanized monoclonal antibody natalizumab have been documented since 2006 from MedWatch reports.

New Formulation: Aztreonam for inhalation (Cayston) was approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas Aeruginosa.

Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna