PHARMACY

Impax gets FDA approval for Mestinon Timespan generic

BY David Salazar

HAYWARD, Calif. — Impax Laboratories has received Food and Drug Administration approval for a generic version of Mestinon Timespan (pyridostigmine bromide extended release) tablets. The drug, intended to treat myasthenia gravis, will be available in 180-mg tablets. It is the first drug to be approved following Impax’s Sept. 4 resolution of issues outlined by the FDA in a warning letter to the company.

“We are pleased to receive approval of generic Mestinon Timespan Tablets, as this is the first generic product approved from the Hayward, CA facility following the resolution of the warning letter,” Impax CEO and president Fred Wilkinson said. “Our pending pipeline of 31 Abbreviated New Drug Applications at the FDA includes 17 products developed in Hayward. Although we cannot predict the timing of subsequent approvals, we are excited about the potential opportunities within our pipeline of products from this facility.”

According to IMS Health data, in the 12 months ending July 2015, Mestinon Timespan had U.S. sales of $45 million. 

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PHARMACY

New CVS Health research pinpoints tendency toward non-adherence

BY Michael Johnsen

WOONSOCKET, R.I. — A new study by researchers at the CVS Health Research Institute and Brigham and Women's Hospital provides evidence that patients' patterns of medication fills in the first few months after starting on a chronic therapy accurately predict future medication adherence behavior. The study, published in The American Journal of Managed Care, suggests that this approach may help quickly identify those patients most likely to benefit from medication adherence interventions. 
 
"This approach is helping us better target interventions to those patients who are most likely to benefit because trajectory modeling differentiates between patients who struggle with adherence at different times during their treatment," said William Shrank, SVP and chief scientific officer, CVS Health and study co-author. "It can also be easily replicated and available to support a wide spectrum of payors and providers who are attempting to improve the quality and reduce the costs of health care. Increasingly, we are finding that, through better analytics, we can deliver the right intervention to the right patient at the right time."
 
"With the increasing availability of rich patient data, we can better anticipate how the patients we manage will take their medications," said Niteesh Choudhry, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and associate professor, Harvard Medical School and the study's senior author. "This research shows that by focusing on a patient's initial, short-term medication filling behavior – are they or are they not refilling their prescription on time during the first few months of therapy – we can predict with great precision whether a patient will continue to take the medication as prescribed over the long-term."
 
The study included claims data from more than 77,000 Medicare beneficiaries that began taking a statin or statin combination drug over a three year period and whose pharmacy benefits are administered by CVS/caremark, the pharmacy benefit management company of CVS Health. Based on patterns of prescription filling over the year following therapy initiation, the researchers used group-based trajectory models to classify patients into six adherence trajectories–ranging from non-adherent to near-perfect adherence–to help capture both duration and intensity of medication taking. 
 
The results showed that patient patterns of initial medication filling in the first two to four months following initiation of a prescription accurately predicted future adherence behavior, allowing precise prediction of the patterns of medication taking over the subsequent year.
 

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PHARMACY

Booming brand-name drugs contribute to growth

BY David Salazar

For the U.S. pharmaceutical market, 2015 is already shaping up to be another double-digit growth year in terms of prescription spend, according to IMS Health data. This year’s moving annual total spending has increased 12.7% to $399 billion, as of June.

One of the largest trends that will define this year is the boom in brand-name drugs — particularly specialty drugs and drugs to treat diabetes. Comparing the percent of spending they contributed to growth in 2011 (58%) to the 2015 MAT as of June (90%) underscores the dominance of branded drugs. In the 12 months ended June 2015, there has been a $19.8 billion increase in new-brand spending, and 75% of that is attributed to specialty medications.

Within specialty pharmacy, growth is particularly rapid in hepatitis C treatments. In the second quarter of 2015, hepatitis drugs spurred 3.3% of the total 13.5% growth in spending. Taking the first half of 2015, hepatitis C treatments have seen $9.6 billion in spending growth — a vast majority of which is for new and protected brands. There is a similar trend for diabetes drugs, which have seen $8.6 billion in growth as of June, with new and protected brands constituting almost the entirety of spending growth.

Despite the increase in money going to prescriptions, though, the growth of the total number of prescriptions being filled has been slowing for several years — only growing 0.1% between 2013 and 2014, with another 0.1% growth predicted based on the MAT from June. This has to do with the fact that despite the spending growth surrounding branded drugs, they still only constitute 16.8% of total prescriptions dispensed.

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