FDA accepts NDA for epilepsy treatment
MARLBOROUGH, Mass. Sepracor announced Monday that the Food and Drug Administration has accepted the new drug application for its epilepsy treatment.
Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. The NDA was submitted Mar. 31 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Meanwhile, the Prescription Drug User Fee Act date for Stedesa is expected to be Jan. 30, 2010, subject to written confirmation, the drug maker said.
Sepracor is seeking approval of Stedesa for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.
“We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy,” said Adrian Adams, president and CEO Sepracor. “Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”
Stedesa, Sepracor said, was studied in three Phase III trials involving more than 1,000 patients in 23 countries. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL, a privately-held Portuguese pharmaceutical company, in late 2007.
NCPA survey: Accreditation requirements hinders pharmacists from offering DME equipment
NEW YORK Almost one-third of those community pharmacists who already offered DMEPOS services responded that they would cease delivering Medicare services if Congress doesn’t act soon.
That should be a wake-up call for Congress.
The reality is the number of community pharmacies that would no longer supply products like diabetes test strips to their Medicare patients is a lot closer to 90% of all community pharmacies, or approximately 20,000 pharmacies, more or less, given that only one in 10 are currently accredited under Centers for Medicare and Medicaid Services guidelines, the fact that the accreditation deadline is only five months away and it takes on average more than six months to become accredited.
To be sure, the survey is a sample of about 1,000 self-reporting pharmacists and there may be a good number of community pharmacists currently pursuing accreditation not included in the 10%, but the bare fact remains that the vast majority of community pharmacies aren’t accredited and will decline to become accredited come Oct. 1.
What does it all mean? To quote Bruce Roberts, NCPA EVP & CEO, it means “the current policy could prevent patients, especially in underserved areas [such as rural communities], from accessing medical supplies that help navigate health challenges such as controlling diabetes.”
Approximately 17.9% of all Medicare households are located in rural communities, according to a Kaiser Foundation report released in February, which means that almost one in five of all Medicare recipients may have greater difficulty accessing their testing supplies.
And that should be a bigger wake-up call for Congress, as well as their Medicare-eligible constituents.
NCPA survey: Accreditation requirements hinder pharmacists from offering DME
ALEXANDRIA, Va. A survey of National Community Pharmacists Association members found that almost one-third (31%) of independent pharmacist-owners in the DMEPOS business would cease offering durable medical equipment, prosthetics, orthotics and supplies to their Medicare patients if new accreditation mandates take effect on Oct. 1.
That includes diabetes supplies.
“Pharmacists have been unfairly singled out for this accreditation rule, but patients will be the ones who truly lose out if this isn’t changed,” stated Bruce Roberts, NCPA EVP and CEO. “These findings illustrate that the current policy could prevent patients, especially in underserved areas, from accessing medical supplies that help navigate health challenges, such as controlling diabetes. We hope Congress will act swiftly with the accreditation deadline fast approaching.”
For those independents currently not in the DMEPOS business, mandated accreditation would significantly deter 67% of those respondents from participating in the future.
Currently, only 1-in-10 community pharmacies currently providing DMEPOS have become accredited. The accreditation fees, training and implementation costs are projected to total at least $5,000 to $7,000, over three years, which is cost prohibitive for many pharmacists.