Bydureon pen gets FDA approval
WILMINGTON, Del. — AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
The Bydureon pen is a pre-filled, single-use pen injector, which eliminates the need for the patient to transfer their medication between a vial and syringe during the process of self-injection. The pen contains the same formula and dose as the original Bydureon single-dose tray.
“We are pleased to receive approval for the Bydureon Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device,” said Briggs Morrison, M.D., EVP of global medicines development and chief medical officer for AstraZeneca. “We are committed to addressing the needs of adults with Type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”
AstraZeneca said it plans to make the pen available for patients later this year. The single-dose tray will remain on the market for patients prescribed Bydureon.
Cardinal Health Specialty Solutions acquires Sonexus Health
DUBLIN, Ohio — Cardinal Health Specialty Solutions on Monday announced the acquisition of privately held Sonexus Health, a Dallas-based company that offers a range of patient access and specialty commercialization services.
“The addition of Sonexus Health to our portfolio brings us even closer to the patient by enabling us to provide a next generation solution to help clients ensure that patients who need specialty medications can get faster access to them and the right services to improve clinical outcomes,” said Scott Howell, SVP clinical affairs for Cardinal Health Specialty Solutions. “Our combined core competencies further strengthen our efforts to help payors, physician practices and biopharmaceutical manufacturers navigate the growing complexity of specialty care.”
Cardinal Health Specialty Solutions clients will now have access to Sonexus Health’s patient services "hub," which serves as a patient and physician practice support center that:
- Reduces administrative burdens by working with patients, physician offices and insurance companies to facilitate treatment coverage and coordinate the medication reimbursement process;
- Improves patient access by identifying appropriate copay assistance and free-drug programs that can make specialty medications more affordable;
- Also improves patient access by delivering medications — based on manufacturer guidelines — with efficiency and supply chain integrity; and
- Helps improve patient outcomes by delivering disease education and medication compliance programs.
In addition, Cardinal Health Specialty Solutions clients will have access to expanded third-party logistics services, enabling them to send higher volumes of smaller parcel shipments directly to physician offices, clinics and hospitals.
The base of Sonexus Health’s operations will remain in Dallas, and customers will continue to be served in the same service model currently offered.
Teva announces launch of Adasuve
JERUSALEM — Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.
Adasuve is administered through Alexza Pharmaceuticals’ Staccato, a single-use, hand-held drug delivery technology system. The drug device combination product provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, a first generation antipsychotic, to the lung, according to the company.
“Existing treatment options for patients with agitation associated with schizophrenia or bipolar I disorder are limited to oral tablets or injectable modes of administration, sometimes requiring the use of restraints,” said Richard Jaffe, M.D., medical director for research and clinical trials at the Belmont Center for Comprehensive Treatment Philadelphia and a clinical trial investigator. “Adasuve is a drug-device combination that offers healthcare providers a new option to help manage agitation.”
Adasuve is currently available through a select distribution network.