From GE:

GE Healthcare commends DEA decision that will make DaTscan™ (Ioflupane I 123 Injection) more available to patients who may have Parkinsonism

September 10, 2015

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GE Healthcare (NYSE:GE) is pleased to announce that the US Drug Enforcement Agency (DEA) has removed the compound ioflupane I 123 from the schedules of the Controlled Substance Act, which has resulted in the descheduling of DaTscan™ (Ioflupane I 123 Injection). DaTscan is the FDA-approved imaging agent which provides an assessment of the integrity of the striatal dopaminergic system via the dopamine transporter to help physicians determine whether patients have essential tremor (ET) or a parkinsonian syndrome (PS) movement disorder such as Parkinson’s disease (PD). The action may help ensure that more healthcare providers and patients with a suspected PS or ET across the United States will have access to imaging with this agent.

DaTscan is a radioactive drug that is injected into the bloodstream to help image areas of the brain using an imaging technique called “SPECT” (single-photon emission computed tomography). For an adult with a suspected PS, a doctor may decide to conduct SPECT imaging with DaTscan, along with other medical tests, to help decide if movement difficulties are due to a PS or a similar condition known as ET. Types of PS include PD, multiple system atrophy, and progressive supranuclear palsy. DaTscan was not designed to differentiate among different forms of PS. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established. Movement disorders are primarily diagnosed through clinical examinations. However, clinical exams alone, particularly early in the disease, may be inconclusive and can result in misdiagnosis. The most common side effects of DaTscan are headache, upset stomach, a sensation of motion, dry mouth, and dizziness.

“We fully support the DEA’s decision to remove ioflupane I 123, the active ingredient in DaTscan, from the Schedules of the Controlled Substances Act,” said Etienne Montagut, global product leader of neurology and cardiology for GE Healthcare. “Because of the DEA’s decision, this important imaging tool will be more widely available to the medical community. Increasing the availability of DaTscan helps us fulfill our commitment to provide innovative, high-quality, and affordable healthcare solutions to patients who need them most.”

“The Parkinson’s Action Network (PAN) applauds the DEA for descheduling the active ingredient in DaTscan and allowing many more people to have access to this important diagnostic tool,” said Ted Thompson, JD, chief executive officer of PAN. “Having this tool available for people with suspected parkinsonian syndromes and essential tremor may help them to receive appropriate diagnosis and treatment sooner.”

Since the approval of DaTscan in 2011, it has been listed by the DEA as a Schedule II controlled substance. This has restricted its use to only those healthcare professionals and imaging facilities registered with the DEA and able to comply with all of the requirements for the appropriate prescribing, storage, use, and disposal of Schedule II controlled substances.  Descheduling has removed these roadblocks, making it easier for imaging specialists to initiate and order DaTscan, as well as to compliantly administer it in their facilities.

GE Healthcare would like to thank the DEA, the US Food and Drug Administration, and the movement disorder community for their collaborative efforts to achieve this important milestone for Parkinson’s patients.