FDA approves Onsolis for cancer patients
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug to treat pain in cancer patients.
The agency approved Miramar, Fla.-based Aveva Drug Delivery Systems’ Onsolis (fentanyl), an opioid medication designed to treat breakthrough pain – pain that “breaks through” regular pain medications – in cancer patients aged 18 and older who need to take an additional opioid medicine and are considered opioid-tolerant.
The drug delivers fentanyl through the mouth’s mucous membranes via an absorbable film that sticks to the inside of the cheek. Because fentanyl is an opioid subject to abuse and misuse, the agency approved Onsolis with a risk-evaluation and mitigation strategy, or REMS, a required plan for managing risks associated with a drug.
“Onsolis can provide strong pain relief to patients who are opioid-tolerant,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said in a statement. “But for patients who are not opioid-tolerant, it can lead to overdose, sudden serious breathing difficulties and death.”
Onsolis is a product of BioDelivery Systems in Raleigh, N.C.
Experts discuss medication adherence
WASHINGTON Poor adherence to medication regimens could counteract the benefits of healthcare reform, a panel of experts concluded Wednesday.
The panel — which brings together experts from GlaxoSmithKline, the National Association of Chain Drug Stores Foundation, the National Consumer’s League and the Pharmaceutical Research and Manufacturers of America — hopes to open a dialogue about medication adherence with between experts from the health, medical, insurance, business, employer, academic and government sectors.
“To date, medication adherence hasn’t been a prominent part of the debate,” conference moderator and founding editor of the journal Health Affairs John Iglehart said in a statement. “But no matter what shape health reform takes, it will ultimately be more successful if it supports the education and motivation of patients to properly follow their medication regimens.”
Participants in the panel will receive briefings on two new research efforts on medication adherence conducted by Avalere Health and the RAND Corp., respectively, using findings from the studies to guide the creation of policy and public education recommendations.
As many as 80% of patients may not be adhering to their medication regimens, according to research, resulting in adverse consequences and draining $100 billion to $300 billion from the healthcare system every year.
MiddleBrook Pharmaceuticals develops copay program for Moxatag
WESTLAKE, Texas A company making a long-acting formulation of a common antibiotic has announced a program to minimize the drug’s cost to consumers.
MiddleBrook Pharmaceuticals announced Wednesday a $20 maximum copay program for Moxatag (amoxicillin) extended-release tablets in the 775 mg strength, designed to keep the drug’s cost to patients at $20 or less. The company said it will field 300 representatives and district managers to begin supplying physicians with voucher cards for the program.
“In this tough economy, we recognize the need to improve Moxatag’s affordability to the patient,” MiddleBrook president and CEO John Thievon said in a statement. “This $20 maximum copay program will replace our current $15 point-of-sale copay check program, which has been in place since Moxatag’s launch.”