Last month, Alkermes announced the initiation of FORWARD (Focused On Results With A Rethinking of Depression), a series of phase 3 clinical trials for ALKS 5461, a once-daily, novel opioid receptor modulator as a potential adjunctive treatment for major depressive disorder (MDD).
The first FORWARD study, evaluating the safety and tolerability of ALKS 5461 in approximately 60 patients with MDD, has already begun, and three core efficacy studies—randomized, controlled trials with approximately 1,500 patients—are expected to begin by this summer. Completion of the FORWARD program will include 12 studies, three efficacy studies, and nine supportive studies, the company noted.
In October 2013, the Food and Drug Administration granted Fast Track status to the development for ALKS 5461 as an additive therapy to standard antidepressants in patients with MDD.
Biogen Idec and Japan-based Eisai have agreed to develop and commercialize potential therapies to reduce accumulation of amyloid-beta plaques in the brains of patients with Alzheimer’s disease (AD). The drugmakers will co-develop E2609, a drug that blocks the conversion of amyloid precursor protein to amyloid-beta, and BAN2401, an antibody that uses the body’s immune system to suppress the progression of amyloid-beta plaques.
Eisai will serve as the regulatory lead in the codevelopment of both drugs. Eisai and Biogen Idec will also co-promote the products once marketing approval has been granted by U.S. and European regulatory bodies. The two companies will share research and development expenses and future revenue.
Biogen Idec CEO George Scangos, Ph.D., said that the new collaboration is a “natural fit” for Biogen, which has a strong focus on patients with neurodegenerative disease. “Eisai is a pioneer in successfully developing and commercializing AD treatments. This history, combined with their strong scientific heritage, geographical reach, and unwavering commitment to the AD community, makes Eisai an excellent collaboration partner to help drive our mission.”
The Alzheimer’s Disease Cooperative Study announced the spring launch of two new clinical trials to combat AD.
The first project, the Study of Nasal Insulin to Fight Forgetfulness (SNIFF), is a research effort led by Suzanne Craft, Ph.D., research director of the J. Paul Sticht Center on Aging at Wake Forest School of Medicine, to determine if a type of insulin, when administered nasally, improves memory in adults aged 55 to 85 who have mild cognitive impairment or AD. According to Craft, insulin resistance, reduced cerebrospinal fluid insulin levels, and reduced brain insulin signals have been found in AD patients, suggesting that a therapy aimed at correcting these deficiencies may be beneficial.
The Anti-Amyloid in Asymptomatic AD (A4) trial is a prevention study led by the director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital, Reisa Sperling, M.D. The study plans to target individuals aged 65 to 85 who have normal cognitive function but may be at risk for developing AD due to the detection of amyloid-beta accumulation by a diagnostic test scan. The participants will be given Eli Lilly’s solanezumab, a drug currently being studied to clear amyloid-beta in the brain.
The A4 and SNIFF trials will be conducted at multiple institutions including the University of California, San Diego; University of Alabama, Birmingham; and Johns Hopkins University School of Medicine. Researchers on the two studies plan to recruit more than 10,000 participants. The SNIFF and the A4 trials are funded by the National Institute on Aging.
In March, Teva Pharmaceutical Industries announced the commercial launch of Adasuve (loxapine), the only orally inhaled medicine available in the United States for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
The delivery mechanism for the aerosol version of loxapine—a first-generation antipsychotic—will be through the Alexza Pharmacuetical’s Staccato inhaler, which will allow the maximum concentration of loxapine to saturate the blood in two minutes, the company noted.
Efficacy for Adasuve was demonstrated in two clinical trials with patients with acute agitation associated with schizophrenia or bipolar I disorder. Results showed a 49 percent reduction in agitation symptoms in schizophrenia patients, compared with 33 percent in those administered placebo, and a 53 percent reduction in bipolar I patients, compared with 27 percent with placebo. Improvements in agitation were significantly reduced two hours after exposure, with some improvements witnessed 10 minutes after dosing.
Because of the risk for bronchospasm, Adasuve is contraindicated for individuals with a history of asthma, chronic obstructive pulmonary disease, or other pulmonary disease.
On March 6, Pfizer voluntarily recalled one lot of 30-count Effexor XR (venlafaxine HCl) 150mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded venlafaxine HC1 150 mg extended-release capsules.
Pfizer chose to recall the lots because a pharmacist reported that one bottle of Effexor XR contained one 0.25 mg capsule of Tikosyn (dofetilide), a drug used to treat irregular heartbeat.
The use of Tikosyn by a current user of Effexor XR/venlafaxine could result in serious adverse health consequences such as abnormal heartbeats and even death, according to Pfizer.
Recalled lot numbers are V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015. ■