31st December 2018 - News report
THE FDA APPROVE THEIR FIRST INHALED L-DOPA
The FDA have approved INBRIJA, which is the first and only FDA approved L-dopa inhaler for intermittent treatment of OFF episodes in people with Parkinson's Disease taking carbidopa/levodopa. It is expected to be available in the first quarter of 2019. It is based on ARCUS® Technology Platform for Inhaled Drug Delivery. For more information go to : http://ir.acorda.com/investors/investor-news/investor-news-details/2018/Acorda-Therapeutic s-Announces-FDA-Approval-of-INBRIJA-levodopa-inhalation-powder/default.aspx
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ARDSLEY, NY–(Business Wire) December 21, 2018 — Acorda Therapeutics, Inc today announced that the US Food and Drug Administration approved Inbrija™ for the intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.
OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
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Big pharma calls it quits on Alzheimer's and Parkinson’s research
Criticisms are flowing from national and international peak bodies as they come to terms with the recent announcement by one of the world’s leading drug makers, Pfizer, to end their research into discovering new medications for Alzheimer's and Parkinson’s. January 2018
Treating Parkinson’s
UNDERSTANDING PARKINSON'S MEDICATIONS
Parkinson’s disease is a very individualized disease and each person who lives with it requires a unique plan. Researchers are attempting to develop treatments that will slow down or reverse the disease, no such therapy has yet been approved by the FDA. The goal is to reduce the symptoms with as few side effects as possible. These are the primary medications indicated for PD, but do not include those used for specific non-motor symptoms. It is important to note that medications work best when they are taken at Exactly the same time, All the time eg. Exactly at 7.00am then Exactly at 11.00am, Exactly at 3pm, and Exactly 7pm for example. The Same Time all the time, based schedule and combined with exercise, good nutrition and adequate sleep.
NPS MedicineWise (NPS)
NPS have created a valuable resource which discusses dementia and medicine.
https://www.dementia.org.au/resources/medicines-and-dementia-what-you-need-to-know
CLASS/TYPE and MEDICATIONS:
Levodopa
Carbidopa/Levodopa (Sinemet)
Carbidopa/Levodopa controlled release (Sinemet CR)
Carbidopa/Levodopa orally disintegrating tablet (Parcopa)
Carbidopa/Levodopa/Entacapone (Stalevo)
How it Works:
Levodopa is the gold standard medication for Parkinson’s with the broadest antiparkinsonian effects of any treatment. In the brain, neurons typically convert levodopa to dopamine. Levodopa works by replacing the dopamine lost in Parkinson’s. It is combined with carbidopa to prevent nausea and ensure levodopa is not metabolized before it enters the brain.
What to Know:
Carbidopa/Levodopa is the most potent and effective medication for Parkinson’s. Parcopa is helpful for people who report daily fluctuations when levodopa wears off. People with Parkinson’s should be aware of which preparation they are taking, as there are many different pill sizes, colours, dose strengths and manufacturers. The decision about when to begin using carbidopa/levodopa is different for every person. Because of debate over a possible toxic effect, some people have been reluctant to begin medication; however, studies have shown no evidence of toxicity. Most neurologists agree that delaying treatment may lower quality of life and may put a person at risk for falling.
Potential Side Effects:
Early in the Parkinson’s course, side effects include low blood pressure, nausea, dry mouth and dizziness. As PD advances, motor side effects such as dystonia and dyskinesia may develop. Confusion and hallucinations are side effects in advanced PD, but less prevalent than hallucinations caused by dopamine agonists. For Stalevo, side effects may include diarrhea, dyskinesia, abdominal pain and harmless discolouration of urine, saliva and/or sweat. The FDA is investigating Stalevo and a possible increased risk of prostate cancer. No conclusions have yet been made. Healthcare professionals should follow current guidelines for prostate cancer screening. People with PD should not stop taking medication unless directed to do so by their doctor.
Dopamine Agonists
Apomorphine (Apokyn)
Bromocriptine (Parlodel)
Pramipexole (Mirapex)
Pramipexole dihydrochloride extended-release (Mirapex ER)
Ropinirole (Requip)
Ropinirole extended-release tablets (Requip XL)
Rotigotine transdermal system (Neupro)
How it Works:
Dopamine agonists are drugs that stimulate the parts of the human brain that are influenced by dopamine. In effect, the brain is tricked into thinking it is receiving the dopamine it needs.
What to Know:
In general, this class of medications is not as effective in relieving symptoms of Parkinson’s as carbidopa/levodopa. The exception is apomorphine, an injectable dopamine agonist that works rapidly, lasts only 30 minutes or so, and may provoke dyskinesias. Doctors often prescribe agonists as an initial therapy in individuals with Parkinson’s, or as a complement to levodopa in people who develop symptom fluctuations.
Dopamine agonists should be started in low doses, with a gradual increase in dosage to prevent side effects. Apomorphine requires training in its administration, and is used as a “rescue” therapy for people who experience sudden spells of wearing-off immobility. The rotigotine patch can be advantageous for individuals seeking a long acting medication, as well as those who are undergoing surgery, and cannot swallow.
Potential Side Effects:
Mild, common side effects include nausea with light-headedness due to low blood pressure. More serious side effects can include hallucinations, sedation (including sudden sleepiness, called sleep attacks) and in some people impulse control disorders (impulsive shopping, gambling, hypersexuality and binge eating). Dopamine agonists may also cause dyskinesias, but are less likely than levodopa/carbidopa to do so. Apomorphine may cause severe nausea, and so people using this agent must take an anti-nausea agent. Some clinicians believe that people with PD can develop a withdrawal syndrome when dopamine agonists are stopped, so a gradual decrease in dosage) rather than stopping the mediation immediately) may be advised.
COMT (Catechol-O-Methyl Transferase) Inhibitors
Entacapone (Comtan)
Tolcapone (Tasmar)
How it Works:
COMT inhibitors are the newest class of PD medications. These agents have no direct effect on PD symptoms, but instead are used to prolong the effect of levodopa by blocking its metabolism.
What to Know:
COMT inhibitors are used primarily to help with wearing-off, a circumstance in which the effect of levodopa becomes short-lived. Entacapone, in addition to being a COMT inhibitor, is also one of the main ingredients in Stalevo, listed under the first class of medications above.
Potential Side Effects:
Side effects include abdominal pain, back pain, constipation, nausea, diarrhea and blood in urine. People who take Tasmar must have regular liver function blood tests. In addition to enhancing the positive effects of levodopa, COMT inhibitors may intensify levodopa side effects including hallucinations and dyskinesia.
MAO-B Inhibitors
Rasagline (Azilect)
Selegiline or deprenyl (Eldepryl)
Selegiline HCI orally disintegrating tablet (Zelapar)
How it Works:
MAO-B inhibitors block an enzyme in the brain that breaks down levodopa.
What to Know:
These drugs have a modest effect in suppressing the symptoms of Parkinson’s. They have been shown to delay the need for levodopa when prescribed in the earliest stage of Parkinson’s, and have been approved for use in later stages of PD to boost the effects of levodopa. Both rasagiline and selegiline have been studied for possible neuroprotection ie whether the drugs can slow down PD progression. In the case of rasagiline, an FDA advisory committee has concluded that more studies are required before the medication can be approved for this indication.
Potential Side Effects:
Depending upon the medication, possible side effects include agitation, dizziness, nausea, headache, rhinitis, back pain, stomatitis, dyspepsia, postural hypotension and indigestion. MAO-B inhibitors may aggravate dopaminergic side effects including dyskinesia and hallucinations. Insomnia is more common with selegiline; therefore it should be taken no later than 1.00pm.
Anticholinergics
Benztropine mesylate (Cogentin)
Procyclidine (not currently available in the US)
Trihexyphenidyl (Artane)
How it Works:
Anticholinergics do not act directly on the dopaminergic system. Instead, they decrease the activity of acetylcholine, a neurotransmitter that regulates movement and memory.
What to Know:
Anticholinergics are the oldest medications for Parkinson’s but they are no longer widely used because of the availability of many other more effective agents. The drugs are used for people with early onset PD who experience mainly tremor. Anticholinergics may ease dystonia that is associated with wearing-off or peak-dose effects.
Potential Side Effects:
Potential adverse effects include blurred vision, dry mouth, constipation and urinary retention. Many people with PD taking Anticholinergics complain of “fogginess” and memory problems. Since older individuals are susceptible, these agents should be avoided in individuals over the age of 70.
Other:
Amantadine
Rivastigmine tartrate (Exelon)
How it Works:
Amantadine promotes the release of dopamine from nerve terminals, blocks its re-uptake and inhibits a glutamate receptor in the brain. It may decrease the activity of acetylcholine, which regulates movement and memory. Rivastigmine tartrate inhibits enzymes that break down acetylcholine.
What to Know:
In the early stages of PD, Amantadine is a mild agent that can be used to help tremor. In later stages of PD, Amantadine has also been found useful in reducing dyskinesias that may occur with levodopa or dopamine agonists. Rivastigmine tartrate is the only medication approved by the FDA for the treatment of dementia in PD. It should be started in low doses, which may be increased gradually.
Potential Side Effects:
Amantadine is a well-tolerated drug, but its potential side effects include dry mouth, constipation, urinary retention, ankle swelling and a mottled skin rash, usually in the legs. In later stages of PD, Amantadine may aggravate hallucinations. Rivastigmine tartrate side effects include diarrhea, dizziness, weakness, drowsiness, trouble sleeping, headache, increased sweating, loss of appetite, nausea, upset stomach and weight loss.
A full description ofeach medication is beyond the scope of this fact sheet, but can be found on PDF’s website at www.pdf.org/meds_treatments (2017).
If you have or believe you have Parkinson’s disease, then promptly consult a physician and follow your physician’s advice. This publication is not a substitute for a physician’s diagnosis of Parkinson’s disease or for a physician’s prescription of drugs, treatment or operations for Parkinson’s disease.
2017 Parkinson’s Disease Foundation
[email protected] www.pdf.org
THE FDA APPROVE THEIR FIRST INHALED L-DOPA
The FDA have approved INBRIJA, which is the first and only FDA approved L-dopa inhaler for intermittent treatment of OFF episodes in people with Parkinson's Disease taking carbidopa/levodopa. It is expected to be available in the first quarter of 2019. It is based on ARCUS® Technology Platform for Inhaled Drug Delivery. For more information go to : http://ir.acorda.com/investors/investor-news/investor-news-details/2018/Acorda-Therapeutic s-Announces-FDA-Approval-of-INBRIJA-levodopa-inhalation-powder/default.aspx
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ARDSLEY, NY–(Business Wire) December 21, 2018 — Acorda Therapeutics, Inc today announced that the US Food and Drug Administration approved Inbrija™ for the intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.
OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
- - - - - - - - - - - - - - - - - - - - - - -
Big pharma calls it quits on Alzheimer's and Parkinson’s research
Criticisms are flowing from national and international peak bodies as they come to terms with the recent announcement by one of the world’s leading drug makers, Pfizer, to end their research into discovering new medications for Alzheimer's and Parkinson’s. January 2018
Treating Parkinson’s
UNDERSTANDING PARKINSON'S MEDICATIONS
Parkinson’s disease is a very individualized disease and each person who lives with it requires a unique plan. Researchers are attempting to develop treatments that will slow down or reverse the disease, no such therapy has yet been approved by the FDA. The goal is to reduce the symptoms with as few side effects as possible. These are the primary medications indicated for PD, but do not include those used for specific non-motor symptoms. It is important to note that medications work best when they are taken at Exactly the same time, All the time eg. Exactly at 7.00am then Exactly at 11.00am, Exactly at 3pm, and Exactly 7pm for example. The Same Time all the time, based schedule and combined with exercise, good nutrition and adequate sleep.
NPS MedicineWise (NPS)
NPS have created a valuable resource which discusses dementia and medicine.
https://www.dementia.org.au/resources/medicines-and-dementia-what-you-need-to-know
CLASS/TYPE and MEDICATIONS:
Levodopa
Carbidopa/Levodopa (Sinemet)
Carbidopa/Levodopa controlled release (Sinemet CR)
Carbidopa/Levodopa orally disintegrating tablet (Parcopa)
Carbidopa/Levodopa/Entacapone (Stalevo)
How it Works:
Levodopa is the gold standard medication for Parkinson’s with the broadest antiparkinsonian effects of any treatment. In the brain, neurons typically convert levodopa to dopamine. Levodopa works by replacing the dopamine lost in Parkinson’s. It is combined with carbidopa to prevent nausea and ensure levodopa is not metabolized before it enters the brain.
What to Know:
Carbidopa/Levodopa is the most potent and effective medication for Parkinson’s. Parcopa is helpful for people who report daily fluctuations when levodopa wears off. People with Parkinson’s should be aware of which preparation they are taking, as there are many different pill sizes, colours, dose strengths and manufacturers. The decision about when to begin using carbidopa/levodopa is different for every person. Because of debate over a possible toxic effect, some people have been reluctant to begin medication; however, studies have shown no evidence of toxicity. Most neurologists agree that delaying treatment may lower quality of life and may put a person at risk for falling.
Potential Side Effects:
Early in the Parkinson’s course, side effects include low blood pressure, nausea, dry mouth and dizziness. As PD advances, motor side effects such as dystonia and dyskinesia may develop. Confusion and hallucinations are side effects in advanced PD, but less prevalent than hallucinations caused by dopamine agonists. For Stalevo, side effects may include diarrhea, dyskinesia, abdominal pain and harmless discolouration of urine, saliva and/or sweat. The FDA is investigating Stalevo and a possible increased risk of prostate cancer. No conclusions have yet been made. Healthcare professionals should follow current guidelines for prostate cancer screening. People with PD should not stop taking medication unless directed to do so by their doctor.
Dopamine Agonists
Apomorphine (Apokyn)
Bromocriptine (Parlodel)
Pramipexole (Mirapex)
Pramipexole dihydrochloride extended-release (Mirapex ER)
Ropinirole (Requip)
Ropinirole extended-release tablets (Requip XL)
Rotigotine transdermal system (Neupro)
How it Works:
Dopamine agonists are drugs that stimulate the parts of the human brain that are influenced by dopamine. In effect, the brain is tricked into thinking it is receiving the dopamine it needs.
What to Know:
In general, this class of medications is not as effective in relieving symptoms of Parkinson’s as carbidopa/levodopa. The exception is apomorphine, an injectable dopamine agonist that works rapidly, lasts only 30 minutes or so, and may provoke dyskinesias. Doctors often prescribe agonists as an initial therapy in individuals with Parkinson’s, or as a complement to levodopa in people who develop symptom fluctuations.
Dopamine agonists should be started in low doses, with a gradual increase in dosage to prevent side effects. Apomorphine requires training in its administration, and is used as a “rescue” therapy for people who experience sudden spells of wearing-off immobility. The rotigotine patch can be advantageous for individuals seeking a long acting medication, as well as those who are undergoing surgery, and cannot swallow.
Potential Side Effects:
Mild, common side effects include nausea with light-headedness due to low blood pressure. More serious side effects can include hallucinations, sedation (including sudden sleepiness, called sleep attacks) and in some people impulse control disorders (impulsive shopping, gambling, hypersexuality and binge eating). Dopamine agonists may also cause dyskinesias, but are less likely than levodopa/carbidopa to do so. Apomorphine may cause severe nausea, and so people using this agent must take an anti-nausea agent. Some clinicians believe that people with PD can develop a withdrawal syndrome when dopamine agonists are stopped, so a gradual decrease in dosage) rather than stopping the mediation immediately) may be advised.
COMT (Catechol-O-Methyl Transferase) Inhibitors
Entacapone (Comtan)
Tolcapone (Tasmar)
How it Works:
COMT inhibitors are the newest class of PD medications. These agents have no direct effect on PD symptoms, but instead are used to prolong the effect of levodopa by blocking its metabolism.
What to Know:
COMT inhibitors are used primarily to help with wearing-off, a circumstance in which the effect of levodopa becomes short-lived. Entacapone, in addition to being a COMT inhibitor, is also one of the main ingredients in Stalevo, listed under the first class of medications above.
Potential Side Effects:
Side effects include abdominal pain, back pain, constipation, nausea, diarrhea and blood in urine. People who take Tasmar must have regular liver function blood tests. In addition to enhancing the positive effects of levodopa, COMT inhibitors may intensify levodopa side effects including hallucinations and dyskinesia.
MAO-B Inhibitors
Rasagline (Azilect)
Selegiline or deprenyl (Eldepryl)
Selegiline HCI orally disintegrating tablet (Zelapar)
How it Works:
MAO-B inhibitors block an enzyme in the brain that breaks down levodopa.
What to Know:
These drugs have a modest effect in suppressing the symptoms of Parkinson’s. They have been shown to delay the need for levodopa when prescribed in the earliest stage of Parkinson’s, and have been approved for use in later stages of PD to boost the effects of levodopa. Both rasagiline and selegiline have been studied for possible neuroprotection ie whether the drugs can slow down PD progression. In the case of rasagiline, an FDA advisory committee has concluded that more studies are required before the medication can be approved for this indication.
Potential Side Effects:
Depending upon the medication, possible side effects include agitation, dizziness, nausea, headache, rhinitis, back pain, stomatitis, dyspepsia, postural hypotension and indigestion. MAO-B inhibitors may aggravate dopaminergic side effects including dyskinesia and hallucinations. Insomnia is more common with selegiline; therefore it should be taken no later than 1.00pm.
Anticholinergics
Benztropine mesylate (Cogentin)
Procyclidine (not currently available in the US)
Trihexyphenidyl (Artane)
How it Works:
Anticholinergics do not act directly on the dopaminergic system. Instead, they decrease the activity of acetylcholine, a neurotransmitter that regulates movement and memory.
What to Know:
Anticholinergics are the oldest medications for Parkinson’s but they are no longer widely used because of the availability of many other more effective agents. The drugs are used for people with early onset PD who experience mainly tremor. Anticholinergics may ease dystonia that is associated with wearing-off or peak-dose effects.
Potential Side Effects:
Potential adverse effects include blurred vision, dry mouth, constipation and urinary retention. Many people with PD taking Anticholinergics complain of “fogginess” and memory problems. Since older individuals are susceptible, these agents should be avoided in individuals over the age of 70.
Other:
Amantadine
Rivastigmine tartrate (Exelon)
How it Works:
Amantadine promotes the release of dopamine from nerve terminals, blocks its re-uptake and inhibits a glutamate receptor in the brain. It may decrease the activity of acetylcholine, which regulates movement and memory. Rivastigmine tartrate inhibits enzymes that break down acetylcholine.
What to Know:
In the early stages of PD, Amantadine is a mild agent that can be used to help tremor. In later stages of PD, Amantadine has also been found useful in reducing dyskinesias that may occur with levodopa or dopamine agonists. Rivastigmine tartrate is the only medication approved by the FDA for the treatment of dementia in PD. It should be started in low doses, which may be increased gradually.
Potential Side Effects:
Amantadine is a well-tolerated drug, but its potential side effects include dry mouth, constipation, urinary retention, ankle swelling and a mottled skin rash, usually in the legs. In later stages of PD, Amantadine may aggravate hallucinations. Rivastigmine tartrate side effects include diarrhea, dizziness, weakness, drowsiness, trouble sleeping, headache, increased sweating, loss of appetite, nausea, upset stomach and weight loss.
A full description ofeach medication is beyond the scope of this fact sheet, but can be found on PDF’s website at www.pdf.org/meds_treatments (2017).
If you have or believe you have Parkinson’s disease, then promptly consult a physician and follow your physician’s advice. This publication is not a substitute for a physician’s diagnosis of Parkinson’s disease or for a physician’s prescription of drugs, treatment or operations for Parkinson’s disease.
2017 Parkinson’s Disease Foundation
[email protected] www.pdf.org