PHARMACY

New NCPA-AADE program gives community pharmacies expanded role in diabetes self-management training

BY DSN STAFF

NEW YORK Here’s the diabetic rub — there is no more efficient way to reach the growing multitudes of diabetics around improving disease-state management and testing/pharmaceutical compliance than through the one touch point with which they interact most often — that being the neighborhood pharmacist.

 

That helps explain why an initiative like this is attractive to NCPA members. More patients are becoming diabetic and are in search of an accessible and trusted healthcare advisor to help them navigate this disease. Why not the healthcare professional that they’re visiting at least once per month, if not more often?

 

But here’s why it’s important for the folks debating healthcare reform in the nation’s capital — intercept the diabetes patient at the point of care they visit most often and you significantly increase the chances they’ll be more compliant with their doctor-prescribed therapy and thereby avoid more serious, and much more expensive, complications down the road. This is an important opportunity for community pharmacy to further demonstrate the important role it can serve in helping this growing patient population better manage the disease, living longer, healthier lives and at less cost to the payer (see Ashville Project, 10 City Challenge), at a time when DMEPOS rules could take many pharmacies out of the diabetes care business altogether.

To summarize — pharmacists save healthcare dollars, and a whole lot of them at that.

Does that sound important? Just ask the payers operating in the Lone Star State, which according to a report issued by the Texas Business Group on Health this week, pay 20% more than your average American to treat diabetes ($63,000). And worse, there are a growing number of diabetics living in the heat of Texas, 74% more in El Paso, for example, and 31% in the Texas metropolis of Dallas.

Texan diabetics would certainly benefit from a program such as NCPA and AADE are developing. Patient compliance (taking prescribed medications) and persistence (total length of time on therapy) in filling their insulin and anti-diabetes prescriptions in 2008 declined consistently month over month across all of the Texas markets profiled in the report.

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Lexicon announces mid-stage trials for three drugs

BY Michael Johnsen

BANGALORE, India Lexicon Pharmaceuticals noted in a statement released earlier this week that it has three products in mid-stage studies targeting rheumatoid arthritis, carcinoid syndrome and irritable bowel syndrome, data from all of which are expected by the end of 2009 or early 2010.

Lexicon initiated a Phase 2 study with LX2931 in patients with rheumatoid arthritis in August 2009.  The clinical trial is planned as a 12-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX2931 and its effects on symptoms associated with rheumatoid arthritis.

Previously, Lexicon successfully completed Phase 1 clinical trials of LX2931. Initial results in healthy volunteers demonstrated a potent, dose-dependent reduction in circulating lymphocytes, suggesting that the target of LX2931 may represent a new mechanism for regulating the immune response.  Lexicon also completed a drug-drug interaction study of LX2931 in patients with rheumatoid arthritis in March 2009.  Top-line results from the trial indicated that LX2931 was well tolerated in combination with methotrexate, and no clinically significant drug-drug interactions were observed.  Methotrexate is the current standard of care for patients with rheumatoid arthritis.

With regard to carcinoid syndrome, a group of symptoms associated with carcinoid tumors — tumors of the small intestine, colon, appendix and bronchial tubes in the lungs, Lexicon initiated a Phase 2 study of LX1032in patients July.  The clinical trial was planned as a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and effects of on symptoms associated with carcinoid syndrome.

LX1032 acts by inhibiting the enzyme tryptophan hydroxylase, the rate-limiting enzyme involved in serotonin biosynthesis and present in metastatic carcinoid tumor cells.  From research conducted in the Genome5000 program, Lexicon scientists found that mice lacking the non-neuronal form of the TPH enzyme have virtually no peripheral serotonin, but do maintain normal levels of brain serotonin.

Also in development, LX1031 for treatment of irritable bowel syndrome also works by inhibiting the enzyme tryptophan hydroxylase. Enrollment in the Phase 2 clinical trial completed in August 2009, four months ahead of schedule.  In all trials completed to date, all dose levels and dosing regimes were well tolerated with infrequent adverse events observed.

LX1031 is an orally-delivered small molecule designed to regulate gastrointestinal function by reducing the amount of serotonin available for receptor activation in the GI tract without affecting serotonin levels in the brain. Serotonin is a key regulator of GI function, and is associated with the most common symptoms of IBS:  problems with bowel motility and GI discomfort.

Unlike LX1031, LX1032 was specifically designed to be better absorbed into the blood stream and, therefore, capable of reducing serotonin production both inside and outside the GI tract without affecting brain serotonin levels.

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FDA tentatively approves Matrix Labs’ combination antiretroviral product

BY Allison Cerra

PITTSBURGH A subsidiary of a generic drug maker has received tentative approval from the Food and Drug Administration under President Obama’s Emergency Plan for AIDS Relief.

Matrix Labs received tentative approval for a combination product of efavirenz (in 600-mg strength), lamivudine (in 300-mg strength) and tenofovir disoproxil fumarate tablets (in 300-mg strength).

Mylan’s product represents the first-ever fixed-dose combination of efavirenz, lamivudine and tenofovir disoproxil fumarate and now provides Matrix with numerous tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first- or second-line treatment in adults, the company said. People use second-line therapies if and when they develop resistance to initially prescribed treatments.

Mylan president Heather Bresch said: “This product represents yet another important advance in our continuing fight against the global epidemic of HIV/AIDS. By combining three antiretroviral products into a once-daily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation also adds another affordable option to our large and rapidly growing portfolio of life-sustaining ARV products.”

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