FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions

FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions

The U.S. Food and Drug Administration (FDA) will not process Acorda Therapeutics‘ marketing application for Inbrija (CVT-301), intended for the treatment of off-periods in Parkinson’s disease, until certain questions are answered.

The FDA’s refusal to accept Acorda’s new drug application (NDA) for Inbrija wasn’t based on safety or efficacy concerns, but was related to the drug candidate’s manufacturing process. In a preliminary review, the FDA found the application lacked certain information needed for a complete review.

Acorda will now seek guidance from the agency to resolve the issues as quickly as possible. They will also ask the FDA to clarify what additional information they require to process the application.

“We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully refile our application,” Ron Cohen, MD, Acorda’s president and CEO, said in a press release.

Inbrija — an inhaled preparation of levodopa — is developed to treat the re-emergence of motor symptoms, often called “off-periods” in Parkinson’s disease patients who take oral levodopa or carbidopa.

Acorda presented data from the SPAN-PD Phase 3 trial (NCT02240030) of Inbrija in June, showing that the higher dose of the drug — 84 mg up to five times a day — showed improved movement after 12 weeks of treatment compared to patients who received a placebo inhalation.

The study, which included 339 Parkinson’s patients, supported findings from an earlier Phase 2b trial that showed better movement ability and less off-time in Inbrija-treated patients.

Another Phase 3 study (NCT02352363), however, failed to show that Inbrija improved lung function among treated patients — a feature Acorda had hoped for.

In its Refusal to File letter to Acorda, the FDA wrote that the application did not specify a date when the drug manufacturing site would be ready for inspection. They also had a question about the submission of the drug master production record.

While these two reasons were the basis of the refusal, the agency also requested additional information from Acorda when the NDA was resubmitted.

The FDA’s rejection of the NDA for Inbrija is the second setback for Acorda in a short time. In late March, a federal court invalidated four patents covering the drug Ampyra (dalfampridine), which improves walking in patients with the neurological disease multiple sclerosis.

The court ruling leaves the door open for other companies to produce generic versions of the drug.

Nevertheless, the company appears convinced that Inbrija will reach Parkinson’s patients in the near future.

“We remain confident in Inbrija’s data package and its promise as an important new therapy for people with Parkinson’s disease,” Cohen said. “We see tremendous long-term value in its solid clinical profile … and we remain focused on working to bring patients this important new therapy.”

2 comments

  1. Richard Miller says:

    I sent this email to this person at merck. This person was no longer at merck two small bio tech companies were bought and sold over this ideal and finally end up at Acorda Therapeutics.
    This email still sits in my sent folder for my gmail account. I am the person who came up with this ideal. Please let me know what you think of this. Email
    to:
    date: Sat, Jul 27, 2013 at 4:45 PM
    subject: carbidopa /levodopa quick absorption
    Good day Caroline
    my name is Richard Miller I am 42
    I have been recently be diagnosed with Yong onset Parkinson’s roughly
    about six months back.
    I like many Parkinson’s patients I take carbidopa/ levodopa though out the day.
    My particular movement disorder I slow or none movement on/in my left
    arm and leg.
    I have observed that first thing in the morning because the dopamine
    medication has been used up while I had been asleep; that I have a
    hard time functioning because of lack of control of muscles on the
    left side.
    Even though I have heard that there is patch in approval stages with the FDA.
    Has any one of your pharmaceutical drug development research managers
    ever suggested a inhaled aerosol version of carbidopa /levodopa. Such
    a product would be most help full first thing in the morning to give a
    Parkinson’s patients a very quick boost of dopamine to get going in
    the morning.
    This inhaled aerosol version could be used in conjunction with a
    transdermal patch.
    Rather than have stumble over to where you keep your medication,
    Dixie cups and water and turn around and wait 20, 30 minutes, and up
    to one hour for the medication to start working. For people with Yong
    onset Parkinson’s who still want and need to work to support them
    self’s financially; this would be a real time saver if you could
    inhale a dose about one hour worth. I take 25-100 mg in one pill so
    one aerosol dose for a single hour would be about 6 or 7 mg carbidopa
    and 26 or 27 mg levodopa.
    And if you are worried about over dosing you can have a small watch
    battery powered circuit in the dispenser which would only allow one
    dose per hour.
    I hope that some one in upper management thinks that could be a good
    product to make.

    Thank your for taking the time to read this email,

    Sincerely,

    Richard E Miller

    • Magdalena Kegel says:

      Hi Richard,

      I’m intrigued to hear you have been thinking about this idea, which researchers have now made into reality.

      Fortunately, FDA’s refusal to process the application of the inhaled version of levodopa, called Inbrija, was only caused by manufacturing details. It is very likely that the treatment will be approved in the near future.

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