Mallinckrodt Pharmaceuticals's Generic ADHD Drug Does Not Measure Up To Johnson & Johnson's Concerta: FDA

Published: Nov 14, 2014

Mallinckrodt Pharmaceuticals's Generic ADHD Drug Does Not Measure Up To Johnson & Johnson's Concerta: FDA

November 14, 2014

By Riley McDermid, BioSpace.com Breaking News Editor, and Jessica Wilson, BioSpace.com Breaking News Reporter

Irish pharmaceutical firm Mallinckrodt has been snubbed by the U.S. Food and Drug Administration, which said this week that its generic attention-deficit hyperactivity disorder drug may not be therapeutically equivalent to primary competitor Concerta and will reclassify the therapy, throwing a major wrench into the company’s plan to get a slice of the billion dollar ADHD market.

The $2.1 billion global pharmaceutical said in a statement yesterday that it had been informed by the FDA that the application of its new Draft Guidance published Nov. 6 raised doubts that the company’s methylphenidate hydrochloride extended-release (ER) tablets had equivalency to Concerta.

As a result, the FDA has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent). The FDA made the change official yesterday in its online Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

According to a statement released by the FDA, “Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours.” The agency’s concern, however, is that, “In some individuals, the Mallinckrodt…products may deliver [the] drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.”

Mallinckrodt makes therapeutic drugs for autoimmune and rare diseases in neurology, rheumatology, nephrology and pulmonology, as well as analgesics and central nervous system drugs for prescribing office- and hospital-based physicians.

The company vigorously defended its methylphenidate ER products, which it said are safe and effective when used in accordance with the approved labels, and are a cheaper generic alternative to Concerta.

“We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients,” said Mark Trudeau, president and chief executive officer of Mallinckrodt, in a statement.

Mallinckrodt said its methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA. It said more than 88 million doses have been prescribed in the 21 months since the product launch.

In that time, there were 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company’s methylphenidate ER products, said Mallinckrodt.

“We believe this very low reporting rate is in line with response rates recorded for patients switching between different formulations of existing products,” said Trudeau. “Based on our review of Mallinckrodt’s safety data base and the conclusions FDA has shared with the company, we remain confident in the safety of our methylphenidate ER products.”

The FDA, however, said that since 2012 it had received more than 200 complaints of “lack of effect” when patients switched from Concerta to Mallinckrodt’s generic version of the drug. The FDA acknowledged that, “the total number of lack of effect reports” is “very small” compared to the overall usage. The cause for concern, though, is “the overall number of complaints” for Mallinckrodt’s drug compared to “the brand-name and [other] authorized generic products.”

Indeed, Mallinckrodt is so adamant about the products’ safety that it said it is contemplating legal action to reinstate the drugs indications. It said the FDA’s recent “unilateral” decision, and “apparent reluctance” to engage with the company in a “thorough” scientific discussion could harm patients, by creating patient anxiety and uncertainty, possible market shortages and the potential disruption of treatment.

“In the face of the agency’s precipitous decision, Mallinckrodt will continue to defend the safety and efficacy of our methylphenidate products,” said Trudeau. “We are considering all of our options to persuade the agency to engage in a meaningful dialog with us regarding the science, including potential legal action.”

In Mallinckrodt’s view, “We have expressed to the FDA our earnest desire to have a robust scientific dialog about these important issues,” said Trudeau, “and it is our hope that this dialogue will take place soon.”

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