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Study: 3-in-4 cancer patients are vitamin D deficient

BY Michael Johnsen

MIAMI BEACH, Fla. — More than three-quarters of cancer patients have insufficient levels of vitamin D, and the lowest levels are associated with more advanced cancer, according to a study presented Oct. 2 at the 53rd Annual Meeting of the American Society for Radiation Oncology.



“Until recently, studies have not investigated whether vitamin D has an impact on the prognosis or course of cancer. Researchers are just starting to examine how vitamin D may impact specific features of cancer, such as the stage or extent of tumor spread, prognosis, recurrence or relapse of disease, and even subtypes of cancer,” stated Thomas Churilla, lead author of the study and a medical student at the Commonwealth Medical College, Scranton, Pa.

The study involved 160 patients with a median age of 64 years split evenly between men and women. The five most common primary diagnoses were breast, prostate, lung, thyroid and colorectal cancer. A total of 77% of patients had vitamin D concentrations either deficient (less than 20 ng/mL) or suboptimal (20-30 ng/mL). The median serum vitamin D level was 23.5 ng/mL. Regardless of the age or sex of the patient, levels of vitamin D were below the median predicted for advanced stage disease in the patient group.

Patients who were found to be vitamin D deficient were administered replacement therapy, increasing serum D levels by an average of 14.9 ng/mL. Investigators will be analyzing if vitamin D supplementation had an impact on aspects of treatment or survival in the long-term.


“The benefits of vitamin D outside of improving bone health are controversial, yet there are various levels of evidence to support that vitamin D has a role in either the prevention or the prediction of outcome of cancer,” Churilla said. “Further study is needed to continue to understand the relationship between vitamin D and cancer.”


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Insomnia treatment under consideration for Rx-to-OTC switch

BY Michael Johnsen

SAN DIEGO — Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

Somaxon Pharmaceuticals and partner Procter & Gamble on Monday revealed the two companies had sat down with the Food and Drug Administration to discuss clinical and regulatory guidance that Somaxon believes provides a clear path forward toward an OTC version of Silenor (doxepin).

The first patent for Silenor currently is set to expire in March 2013 — a prescription-only generic version of the medicine cannot be introduced prior to this. Silenor generated $6.2 million in prescription sales for the second quarter ended June 30, Somaxon reported.

Silenor is a tricyclic antidepressant that also is used as a hypnotic to initiate and maintain sleep. It was approved by the FDA for treatment of insomnia in March 2010. The point of differentiation for the insomnia population is that Silenor is not habit-forming. Abuse potential is a significant concern for people seeking sleep aids.

However, there will be a number of hurdles with any OTC switch attempt. Complex behaviors, such as "sleep-driving," are addressed within the prescribing information for the medicine, as is a potentiality for suicidal ideation. The active ingredient in Silenor — doxepin — works as an antidepressant at doses of between 10-times and 100-times the recommended dose of Silenor.

Somaxon believes that the FDA’s guidance provides an opportunity to develop an OTC label that is tailored to Silenor’s clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor’s characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.

“Our first year of marketing Silenor has provided us with a host of learnings relating to the market and the most efficient use of our resources to promote Silenor for the treatment of insomnia,” stated Richard Pascoe, Somaxon’s president and CEO. “The changes to the Procter & Gamble agreement [extending P&G’s exclusive negotiation period relating to OTC rights to Silenor from 60 to 120 days] represent the natural evolution of our relationship at this stage in Silenor’s commercial growth, allowing us to reallocate resources from sales support toward Silenor consumer awareness initiatives, while continuing to explore the potential for a Silenor OTC life cycle management opportunity with a highly differentiated label."


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MinuteClinic opens two clinics in Savannah region

BY Allison Cerra

WOONSOCKET, R.I. — MinuteClinic continues to expand its reach by opening two walk-in medical clinics inside CVS/pharmacy stores in the Savannah, Ga., market.

The clinics, located in Savannah and Richmond Hill, are the first retail medical clinics to open in the region and join 31 other MinuteClinic locations in Georgia situated throughout the Atlanta metropolitan area.

The openings are part of MinuteClinic’s goal to open 100 walk-in clinics nationwide this year.

"Since opening our first store-based clinic in Georgia in 2007, we have helped to expand access to high-quality, convenient and affordable care to thousands of residents who have visited us at convenient CVS/pharmacy locations near where they live and work," said Andrew Sussman, MinuteClinic president and sSVP/associate chief medical officer for CVS Caremark. "We are committed to making our innovative model of care part of Georgia’s efforts to broaden access to quality health services."


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