Antares announces availability of injectable methotrexate product for arthritis, psoriasis
EWING, N.J. — A new drug for autoimmune diseases from Antares Pharma that the company calls the first of its kind is now available, the drug maker said Wednesday.
Antares announced the availability of Otrexup for rheumatoid arthritis and psoriasis in adults and polyarticular idiopathic arthritis in children. The company said the drug is the first Food and Drug Administration-approved subcutaneous methotrexate product for once-weekly self-administration. Otrexup, which the FDA approved in October, is available with a single-dose auto injector.
"Otrexup provides an attractive new option that may benefit patients who have had an inadequate response to or are intolerant of oral [methotrexate]," Antares president and CEO Paul Wotton said. "Otrexup is an easy-to-use auto injector that delivers greater blood levels of medication than oral MTX. Otrexup could extend the use and benefits of MTX and potentially delay or avoid the use of other more expensive treatment options in some patients."
Reports: Ill. pharmacists hope to dispense medical marijuana
NEW YORK — Pharmacists in Illinois are pushing for the state to let them run medical marijuana dispensaries, according to published reports.
The Chicago Tribune reported that pharmacists are trying to get the state to reclassify marijuana as a Schedule II controlled substance. Currently, the Drug Enforcement Administration classifies it as Schedule I, making it illegal in all circumstances at the federal level; the proposed rescheduling would mean it was legal for medical use, but still tightly regulated, similar to opioid painkillers.
On Jan. 1, Illinois enacted a law allowing medical marijuana for nearly three dozen chronic medical conditions, but pharmacists remain prohibited from dispensing it. Still, the Tribune quoted Lincolnshire, Ill., pharmacist Joseph Friedman as saying, "It makes perfect sense. After all, pharmacists are the drug experts," noting that pharmacists understand dosing, side effects and drug interactions.
Still, according to the Tribune, groups like NORML, an organization that supports full legalization of marijuana, oppose medical marijuana at pharmacies, fearing that drug companies will take control of the nascient industry, while the Illinois Pharmacists Association said it would support medical marijuana if it underwent a regulatory approval process at the federal level similar to prescription drugs and drug companies sold it in a standardized form.
Illinois is not the first state to look at medical marijuana sales at pharmacies. Recently, Gov. Rick Snyder of Michigan signed into law legislation that would allow pharmacies in the state to dispense medical marijuana as long as it’s legalized for medical purposes at the federal level.
New York could also be the next state to legalize medical marijuana. Gov. Andrew Cuomo recently announced a plan for limited legalization of medical marijuana, allowing up to 20 hospitals to dispense it under a 1980 state law, though the New York State Assembly Health Committee on Tuesday also passed legislation that would legalize it in the state; the full Assembly passed a medical marijuana bill last June, but it failed in the Senate. Meanwhile, voters in Washington and Colorado passed referendums legalizing recreational use of marijuana, with the Colorado law taking effect at the start of the month. Currently, 20 states and the District of Columbia allow medical marijuana, while Maryland allows medical use of the drug as a defense in court cases.
Perrigo launches generic equivalent to prescription-only Vanos Cream 0.1%
DUBLIN — Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.
Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.
Vanos Cream 0.1% (fluocinonide cream 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older and has estimated annual sales of approximately $107 million.