PediatRx, Inc. (OTCBB: PEDX) announced that the U.S. Centers for Medicare and Medicaid Services (CMS) recently notified state Medicaid agencies to include PediatRx's GRANISOL, NDC 52547-0801-30, in their list of reimbursed products. CMS funds the Medicaid and State Children Health Insurance Programs jointly with state governments. These programs provide health insurance, including prescription drug coverage, to over 40 million low-income families,* and this number is expected to grow with the implementation of health care reform legislation.

Dr. Cameron Durrant, founder of PediatRx, said, "We are delighted to have reached an agreement with CMS to include PediatRx's GRANISOL on the list of reimbursed products for Medicaid. This means that individual state Medicaid programs can now add GRANISOL to their formularies, enabling patients enrolled in Medicaid access to the only once-daily oral solution of granisetron."

CMS provided in its notice to PediatRx two effective dates: an optional effective date of March 17, 2011, and a mandatory effective date of July 1, 2011. States can begin covering GRANISOL at their option any time between these two dates. Patients and health care providers can contact their state Medicaid program to find out if GRANISOL has been added at the current time. See here.

Durrant continued, "We are acutely aware of the financial pressures on patients, including those who are not eligible for government-sponsored healthcare programs or are uninsured or underinsured. That is why we developed a co-pay assistance program, GRANI Cares, to support GRANISOL for eligible patients."

For patients who are not enrolled in Medicaid or Medicare, visit GRANI Cares: see here.

GRANISOL is indicated for the prevention of:

- Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

- Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Selected Safety Information

- GRANISOL is contraindicated in patients with known hypersensitivity to the drug or any of its components.

- QT prolongation has been reported with granisetron. Therefore, GRANISOL Oral Solution should be used in caution with patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.

- Safety and effectiveness in pediatric patients have not been established.

- The most common side effects observed with administration of granisetron were headache, asthenia, constipation, diarrhea, dyspepsia, and abdominal pain.

*2009 U.S. Census Bureau.

Source:
PediatRx, Inc.