Reading Between The Lines
Aducanumab developed by the biotechnology firm Biogen in Cambridge, Massachusetts followed an unusual route to approval. In March 2019, Biogen halted two phase III trials of the drug candidate after an interim analysis showed that it was unlikely to improve cognition for people with mild Alzheimers. But when Biogen re-evaluated the data and found that a subset of people in one of the trials might have benefited, it reversed course the firm submitted aducanumab for approval in 2020.
The FDAs eventual decision to ignore the advice of its advisory committee and approve the drug, it says, was based on aducanumabs ability to lower levels of amyloid plaques in the brain protein clumps that some scientists think cause Alzheimers.
Instead of granting the drug a standard approval, which is typically reserved for agents that have demonstrated benefit for people in large phase III trials, the FDA opted to use its accelerated approval pathway. This is for treatments that are reasonably likely, but not certain, to help patients.
In large trials of other Alzheimers drug candidates, amyloid lowering has not led to cognitive benefits, and this has made it a sticking point for researchers.
Insightec Announces Fda Approval Of Exablate Neuro For The Treatment Of Parkinsons Disease
MIAMI, Nov. 3, 2021 /PRNewswire/ Insightec®, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the U.S. Food and Drug Administration has approved the Exablate® Neuro for treating advanced Parkinsons Disease patients suffering from mobility, rigidity, or dyskinesia symptoms.
The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy. The treatment is incisionless, does not require brain implants, and has less risk of infection than invasive surgery.
Movement disorder neurologists now can offer their Parkinsons patients a less invasive surgical option as part of their treatment plan, Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.
This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinsons disease, added Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.
Exablate, and Exablate Neuro, as well as the INSIGHTEC logo, whether standing alone or in connection with the word Insightec, are protected trademarks of Insightec.
G& S Business Communications for Insightec
Which Approved Medications Are Being Tested In Parkinsons
Despite this, efforts to find approved medications that benefit people with PD continue. Below is a list of medications that are already approved for use in other conditions and are currently being tested for PD :
We will be keeping an eye on these trials and remain hopeful that new treatment options will result from this research.
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How Does A Medication Approved For One Indication Become A Possibility For Treating Parkinsons
This jump may occur if pre-clinical research, that is, research that is done in cell culture or PD animal models, suggests that a known drug may have efficacy in PD. Just because a drug shows neuro-protective properties when placed in a cell culture or improves parkinsonian symptoms when given to a mouse, does not mean that this will translate into a clinically meaningful difference if taken by people with PD. Therefore, observations made in a lab must be confirmed in clinical trials.
Another method by which an approved medication may gain consideration for use in PD is through mining large databases of medical information. Through epidemiological data, it may be noted for example, that those who have been prescribed a particular medication have lower rates of PD. This information may be intriguing, but is far from enough information to conclude that taking the medication caused the lower rates of PD. And even if the medication does directly contribute to lower rates of PD, there may be no clinical effect of taking the medication in people who already have PD. Therefore, any suggestion of a medication benefit for PD gleaned from epidemiological data must be tested in a clinical trial.
On Times And Off Times
ON time refers to periods when medications are adequately working and the symptoms of Parkinsons disease are controlled.
OFF time refers to periods when the medications wear off and Parkinsons symptoms, such as tremor, rigidity, and difficulty walking reappear.
The addition of safinamide to drug regimens of people with advanced Parkinsons disease taking levodopa increases the amount of ON time and decreases OFF time.
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Fda Approves Ind For Ketamine In Parkinson Disease Dyskinesia
An upcoming phase 2 trial will assess ketamine in up to 36 patients, using change in the Unified Dyskinesia Rating Scale as the primary end point of the study.
The FDA recently approved PharmaTher Holdings investigational new drug application for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson disease , with a phase 2 clinical trial on the way.1
The phase 2 trial will evaluate the safety, efficacy, and pharmacokinetics of ketamine in this population and is expected to begin patient enrollment in the third quarterof 2021. PharmaTher also noted that pending the success of the trial, the company will seek an agreement with the FDA to move to a phase 3 clinical study under the 505 regulatory pathway next year.
“The FDAs acceptance of our IND application for ketamine to treat Parkinson disease is a significant milestone for us. The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug, Fabio Chianelli, chief executive officer, PharmaTher, said in a statement.1
PharmaTher intends to enroll a target number of 36 individuals randomized to either ketamine or midazolam , the active control, in the phase 2 clinical trial. Investigators will use change in the Unified Dyskinesia Rating Scale total score from baseline to week 8 as the primary end point.
Fda Approves Focused Ultrasound For Parkinsons Symptoms
Jeff Elias, MD, pioneered the use of focused ultrasound for the treatment of essential tremor and Parkinsons disease.
The federal Food and Drug Administration has approved an incisionless form of brain surgery to treat advanced Parkinsons disease after successful testing at the School of Medicine and other sites.
The authorization allows the use of Insightecs Exablate Neuro focused ultrasound device to treat problems with mobility, rigidity and involuntary movements known as dyskinesias that are common in Parkinsons. UVA is one of only 37 medical centers in the country with the capacity to offer this minimally invasive treatment, according to the Charlottesville-based Focused Ultrasound Foundation, a longtime supporter of UVAs pioneering research into the many potential applications of the technology.
Prior to the approval, available treatments for the Parkinsons symptoms included drugs, which not all patients respond to, and invasive deep-brain surgeries. Focused ultrasound, in comparison, does not require incisions or cutting into the skull. Instead, the technology focuses sound waves inside the brain to interrupt faulty brain circuits, much like a magnifying glass can focus light to create heat. During the focused ultrasound procedure, doctors use magnetic-resonance imaging to peer inside the brain in real-time before making any permanent changes, helping ensure patients get the best possible outcomes.
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Avion Pharmaceuticals Llc An Alora Pharmaceuticals Company Announces The Fda Approval And Availability Of Dhivy For The Treatment Of Parkinsons Disease
Parkinsons Disease Treatment is the First and Only Carbidopa/Levodopa TabletDesigned to be Divided for Precise Dosing
Avion Pharmaceuticals, LLC, an Alora Pharmaceuticals company, announced the commercial launch of DHIVY, the first and only carbidopa/levodopa fractional tablet designed to be divided. Avion gained approval for DHIVY from the FDA in November 2021. This unique design enables more precise medication dosing and directly addresses a market need to assist in titration for the gold standard commonly used by those with Parkinsons Disease , the fastest-growing neurological condition in the United States, for which there is currently no cure.
DHIVY is the first and only functionally fractional carbidopa/levodopa tablet.
DHIVY was developed by two neurologists who recognized the need for a CD/LD tablet that could be easily individualized. The fractional tablet technology is designed with deep scores that enable patients to divide it precisely to match their recommended dose. Each tablets four segments contain 6.25/25 mg of CD/LDthe smallest, precise dose available in todays market. The American Academy of Neurology in its updated treatment guidelines for early Parkinsons disease recommends initiating patients with the lowest effective dose of immediate-release carbidopa/levodopa.
The company expects DHIVY will be commercially available at retail pharmacies as of Monday, February 14th, 2022. For more info about DHIVY, please visit dhivy.com.
Treatment Improves Off Time When Used As Add
SILVER SPRING, Md. The FDA approved istradefylline as an add-on treatment to levodopa/carbidopa in adult patients with Parkinsons disease experiencing off episodes, the agency announced late Tuesday.
Istradefylline is an orally administered, selective adenosine A2A receptor antagonist and has been as adjunctive treatment to levodopa-containing products for Parkinsons patients.
The FDA decision this week caps drugmaker Kyowa Kirins second try at winning approval in 2008, the agency rejected the drug due to efficacy concerns.
This time, the company presented four 12-week placebo-controlled clinical studies, involving 1,143 Parkinsons disease patients on levodopa/carbidopa, to demonstrate istradefyellines effectiveness. In all four studies, patients treated with istradefylline showed reductions from baseline in daily off time relative to patients using placebo.
The most common adverse reactions experienced in the trials were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia. Patients should be monitored for the development or exacerbation of existing dyskinesia, the FDA said if hallucinations or psychotic or impulsive/compulsive behaviors occur, the dose should be reduced or the drug should be stopped. Istradefylline is not recommended for pregnant women.
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Medications To Avoid Or Use With Caution
Sign up for our email list and receive our publication on medications with potential complications you should be aware of.
Before making any decisions about treatment of Parkinsons disease, you will want to learn about the different types of medications available for Parkinsons disease and discuss the pros and cons of each with your physician. It may help to know that there is no right answer, and if you try something that doesnt work for you, you can always adjust your plan.
To learn more about adjusting medication plans, view our webinar on What to Do When Your Medications Stop Working.
Medication Guidelines For Parkinson’s Disease
There is no one best mix of Parkinsonâs medicines. You and your doctor will have to try a few treatment approaches to figure out the best one for you.
But there are some general guidelines for taking your medication. Be sure to ask your doctor or pharmacist for any specific tips for your treatment.
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Focused ultrasound, in comparison, does not require incisions or cutting into the skull. Instead, the technology focuses sound waves inside the brain to interrupt faulty brain circuits, much like a magnifying glass can focus light to create heat. During the focused ultrasound procedure, doctors use magnetic-resonance imaging to peer inside the brain in real time before making any permanent changes, helping ensure patients get the best possible outcomes.
This FDA approval of focused ultrasound pallidotomy allows for more treatment options if medications become ineffective or cause disabling side effects, said UVA Health neurosurgeon Dr. Jeff Elias, a pioneer in the field of focused ultrasound who led UVAs testing of the technology for treating Parkinsons. While this procedure does not provide a cure for Parkinsons disease, there is now a less-invasive option for patients suffering with medication-induced dyskinesia or severe motor deficits.
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Full List Of Medications Approved For The Treatment Of Parkinsons Disease In The Usa
Below is a full list of Parkinsons medications that have been approved to treat Parkinsons in the United States. This material is intended to provide you with information. It should not be used for treatment purposes, but rather as a source for discussion with the patients own physician. Work with your physician to determine which medications are best for you, and know the risks and benefits of each.
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What Is Parkinsons Disease
Parkinsons disease is a progressive brain disorder that causes shaking and muscle stiffness, and slows movement. It develops when neurons in a particular part of the brain stop working properly and are lost over time. These neurons produce an important chemical called dopamine. Dopamine is used by the brain to send messages across brain areas to help control movement. Eventually, the brain cannot make enough dopamine to control the movement properly.1,2
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The Power And Potential Of Focused Ultrasound
Research into focused ultrasound to treat a variety of conditions has been going on for over a decade. While neurosurgeon Jeff Elias research has shown the capabilities of focused ultrasound in treating tremors, other UVA colleges are currently investigating the technologys potential to benefit a huge array of conditions, from breast cancer to epilepsy to opening the brains natural protective barrier to admit treatments never before possible.
Due to the unique nature of this new treatment, it can be performed on an outpatient basis and without any incision, which will prove to be a popular and lifechanging choice for the Parkinsons patients that can access it.
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About Avion Pharmaceuticals Llc
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to develop, acquire and market a portfolio of innovative pharmaceutical products in the Womens Health and other therapeutic categories aligned with our mission to improve the quality of patient lives. Avion Pharmaceuticals focuses on identifying opportunities to develop, acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs. For additional information about Avion Pharmaceuticals, please contact the company at 888-612-8466. For more information, visit www.avionrx.com.
Importance Of The Patient Community Input
The primary task for the iLCT committee is appropriate drug selection. An important part of the deliberation is focused on safety and considerable thought is also given to patient wellbeing. At every iLCT meeting, patient advocates are invited as representatives for the PD community, and their input to the discussion is sought-after and greatly valued. For all drugs considered, special consideration must be given to whether any particular therapy is appropriate as a potential treatment for the cohort of interest taking into account the practicalities of mobility and the predominant age bracket of the patients. Factors such as drug formulation and frequency of dosing are sometimes discussed. Unique insights can be gained from the lived experience provided by the patient advocates, and this can impact which of the agents considered by the committee are eventually selected to enter clinical trials.
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Levodopa: The Most Effective Drug For Treating Parkinsons
Levodopa, also known as L-DOPA, has long been, and continues to be, the most effective drug in treating Parkinsons disease symptoms. Most people with Parkinsons disease will take this drug at some point. There are side effects that can occur with Levodopa including nausea, fatigue and orthostatic hypotension. Often these side effects can be successfully treated so that Levodopa can be tolerated better. In addition, as the disease progresses and the brain has less ability to produce and process dopamine, dyskinesias, or involuntary movements can develop from Levodopa.
Where Do The Dopamine Receptor Agonists Fit In The Overall Strategy For Optimizing The Treatment Of Parkinsons Disease
Dopamine agonists can be used as monotherapy, or as the only drug taken for PD. In addition, they can be used as adjunctive or add on medications to supplement the use of levodopa when further dopaminergic effect is desired or when complications of levodopa treatment, such as dyskinesias, wearing off, and motor fluctuations, are encountered.
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Pd And Medication: Whats New
Since its launch in the late 1960s, carbidopa/levodopa is still the most effective Parkinsons disease motor symptom treatment. However, it doesnt address all facets of the disease. Medications to bolster its effectiveness and treat PD-related non-motor symptoms are newly available or just on the horizon.
This article is based on a Parkinsons Foundation Expert Briefings webinar exploring innovative PD treatments by Rajesh Pahwa, MD, Director, Parkinson and Movement Disorder Division, University of Kansas Medical Center, a Parkinsons Foundation Center of Excellence.
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