1st drug OK'd for movement disorder caused by certain meds - KAIT Jonesboro, AR - Region 8 News, weather, sports

1st drug OK'd for movement disorder caused by certain meds

(Neurocrine Biosciences, Inc. via AP). This photo provided by Neurocrine Biosciences, Inc. shows the label on a bottle of the drug Ingrezza. On Tuesday, April 11, 2017, the Food and Drug Administration approved Ingrezza, the first drug for treating a n... (Neurocrine Biosciences, Inc. via AP). This photo provided by Neurocrine Biosciences, Inc. shows the label on a bottle of the drug Ingrezza. On Tuesday, April 11, 2017, the Food and Drug Administration approved Ingrezza, the first drug for treating a n...
By LINDA A. JOHNSON
AP Medical Writer

TRENTON, N.J. (AP) - U.S. regulators have approved the first drug for treating a neurological syndrome that causes uncontrollable body movements that can also interfere with speech, swallowing and breathing.

The sometimes-disabling disorder, tardive dyskinesia, is caused by some widely used prescription medicines for psychiatric and gastrointestinal disorders. It can surface while patients are on those medicines or years after they stop. It affects about 500,000 U.S. patients.

The Food and Drug Administration on Tuesday approved Ingrezza, developed by Neurocrine Biosciences, for treating adult patients. The San Diego-based biotech company didn't disclose the drug's list price, but said it will when it begins offering the once-a-day capsule for sale in May.

A second drug for the disorder, from Israel's Teva Pharmaceuticals, is expected to win FDA approval in late August.

Tardive dyskinesia causes repetitive, involuntary movements, including rapid eye blinking, grimacing, lip-smacking and rapid movements of the trunk, arms and legs. It can be embarrassing for patients and lead to social withdrawal and job loss.

The condition usually occurs after long-term use of drugs that block important receptors in the brain that help regulate movement and motor function.

Those drugs include newer pills for schizophrenia and related psychiatric disorders that were touted as safer than older antipsychotic drugs, a claim that led to them being widely prescribed for depression, bipolar disorder and other conditions.

Patients taking certain drugs for acid reflux and other stomach disorders, such as metoclopramide, also have developed tardive dyskinesia.

Until now, treatment generally was limited to stopping or reducing the dosage of the psychiatric or stomach medication, or switching to a different medication. However, stopping the original medication doesn't halt tardive dyskinesia in most patients, and doing so can destabilize schizophrenia patients, according to Neurocrine's chief executive, Kevin Gorman.

Ingrezza, known chemically as valbenazine, was tested on more than 1,000 patients. In the final stage of testing, 40 percent of patients given a high dose of Ingrezza saw their movement symptoms decrease by at least half after six weeks, compared to about 19 percent of those getting dummy capsules, Neurocrine reported.

Gorman said study participants who kept taking it after the six weeks had additional improvement and after a year, a small percentage who stopped taking Ingrezza then found their tardive dyskinesia symptoms didn't return.

Ingrezza's possible side effects were rare and include fatigue, restlessness, dry mouth, headaches and joint pain.

The drug is also being tested in patients as a possible treatment for Tourette's syndrome.

___

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma .

Copyright 2017 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • Latest health & fitness newsLatest health & fitness newsMore>>

  • Lawmakers revisiting requiring those on Medicaid to work

    Lawmakers revisiting requiring those on Medicaid to work

    Saturday, April 22 2017 9:02 PM EDT2017-04-23 01:02:26 GMT
    Saturday, April 22 2017 9:02 PM EDT2017-04-23 01:02:26 GMT
    The Trump administration and the Republican-led House are revisiting the question of whether adults who are able to work should be required to work to get taxpayer-provided health insurance.
    The Trump administration and the Republican-led House are revisiting the question of whether adults who are able to work should be required to work to get taxpayer-provided health insurance.
  • Campus vending machine sells morning-after pill

    Campus vending machine sells morning-after pill

    Friday, April 21 2017 8:39 PM EDT2017-04-22 00:39:56 GMT
    Friday, April 21 2017 8:57 PM EDT2017-04-22 00:57:55 GMT
    Students at the University of California-Davis can now get the so-called "morning after pill" in a vending machine on campus. (Source: KTXL/CNN)Students at the University of California-Davis can now get the so-called "morning after pill" in a vending machine on campus. (Source: KTXL/CNN)

    The vending machine, which also offers pregnancy tests, tampons and Advil, is at UC-Davis. 

    The vending machine, which also offers pregnancy tests, tampons and Advil, is at UC-Davis. 

  • Poll: Americans overwhelmingly support legalizing medical pot

    Poll: Americans overwhelmingly support legalizing medical pot

    Friday, April 21 2017 4:05 PM EDT2017-04-21 20:05:33 GMT
    Friday, April 21 2017 4:05 PM EDT2017-04-21 20:05:33 GMT

    Two-thirds of Americans also believe pot is safer than opiod pankillers and would likely use it for pain if a doctor prescribed it.

    Two-thirds of Americans also believe pot is safer than opiod pankillers and would likely use it for pain if a doctor prescribed it.

Powered by Frankly