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FDA approves new dosage strength of Purdue Pharma’s Butrans

BY Ryan Chavis

STAMFORD, Conn. — Purdue Pharma announced that the Food and Drug Administration approved a new 7.5-mcg/hour dosage strength of Butrans (buprenorphine) transdermal system CIII, which brings the total strengths of the drug to five. Other dosage strengths include 5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.

The system also is approved to allow use of two patches to help with dose adjustments during titration, the company said, adding that the total dose from both patches shouldn't exceed 20 mcg/hour. Purdue expects to launch the new dosage strength in the United States in October 2014.

"This approval provides healthcare professionals another option to tailor Butrans therapy to the individual needs of appropriate chronic pain patients," said Todd Baumgartner, M.D., MPH, VP research and development and chief medical officer at Purdue Pharma L.P. "The introduction of the 7.5-mcg/hour dosage strength further demonstrates Purdue's ongoing commitment to the management of chronic pain."

Butrans is used for the management of pain that's severe enough to require daily, long-term opioid treatment. Because of the risks of addiction, as well as abuse and misuse with opioids, the company noted that Butrans should be reserved for patients whose alternative treatment options have proven ineffective or not tolerated, or would be "otherwise inadequate to provide sufficient management of pain."
 

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Walgreens: Utilization of retail clinics for chronic, preventive care on the rise

BY Michael Johnsen

DEERFIELD, Ill. — A new research study from Walgreens released Thursday found that patients are relying more on nurse practitioners at retail clinics to provide chronic and preventive health services. The study also revealed marked increases in the number of patients who are making return visits to clinics.
 
The Walgreens study found the percentage of visits to Healthcare Clinic locations for preventive services, screening and chronic visit utilization (combined) increased from 4% in 2007 to 17% in 2013. The study also found the annual percentage of return patient visits to Healthcare Clinics climbed from 15% in 2007, to more than 50% in both 2012 and 2013.  
 
“Access to care in the community, and the growing need to support patients with chronic diseases are two of the biggest challenges facing our health care system,” stated Harry Leider, Walgreens chief medical officer. “This further demonstrates that retail clinics can be instrumental in providing that care, driving patient engagement, and working in coordination with physicians and other primary care providers to foster continuity of care to support more patients.” 
 
Additional study findings include:
 
  • For patients age 17 years and under, visits for both preventive services and vaccinations increased by 180%;
  • For patients ages 18  to 64 years, visits for health testing increased by 90%, while overall preventive health service visits increased 66%; and
  • For patients age 65 years and older, acute visits increased 84%.
 
“More consumers are relying on Healthcare Clinic and our nurse practitioners as a trusted source of quality care,” commented Suzanne Hansen, Walgreens group VP, Healthcare Clinic. “Our expansion of chronic and preventive services last year is helping to drive more return visits from our patients, which is key to the patient-provider relationship and our ability to deliver personalized care.” 
 
The findings were presented last week at the National Nurse Practitioner Symposium in Keystone, Colo., and were based on a retrospective longitudinal study examining patient visits to Healthcare Clinic at select Walgreens from 2007 through 2013. The symposium gathered industry experts to share insights and strategies for the specialty and traditional pharmacy benefit. 
 
With the current locations and clinic count, the Convenient Care Association estimates that 33% of Americans live within 10 minutes of a retail healthcare clinic. The variety of services offered at Healthcare Clinic at select Walgreens has increased over the course of the past several years from providing vaccinations at the beginning, to diagnosing and treating a number of chronic conditions today.
 

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Mylan awarded permanent injunction against GlaxoSmithKline in relation to generic Paxil CR

BY Michael Johnsen

PITTSBURGH — Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR. GSK is now precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan had previously been awarded damages in the amount of $106.7 million by the District Court after a favorable jury verdict in March 2014.  
 
In addition, the District Court awarded Mylan prejudgment interest and permitted it to take an accounting so that Mylan can determine the amount of additional damages it has suffered since Sept. 30, 2013 as a result of GSK's ongoing breach. All of GSK's post-trial motions were denied.
 
Mylan is the only company to have successfully developed an FDA-approved generic version of this product, the company stated.
 

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