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Hello, I’m Looking To Compare Drugs For Research Purposes And
Question: Hello, I’m looking to compare drugs for research purposes and was wondering if the following can be seen as substitutes? Why or why not? Thank you!
1. to treat Alzheimer's disease (Neuroscience and Pain)
Cerebrolysin (FPF 1070) vs Namenda (Namzaric, Memantine)
ABBV-8E12 vs Namenda (Namzaric, Memantine)
2. to treat Migraine (Neuroscience and Pain)
Depakote (valproate semisodium) vs Botox (onabotulinum A)
3. to treat Bipolar Disorder (Neuroscience and Pain)
Depakote (valproate semisodium) vs Vraylar (cariprazine)
4. to treat Parkinson’s (Neuroscience and Pain)
Duodopa (Levodopa/carbidopa) vs LTI-291
Also, if you have any market share information available for any of the above indications, please provide. Thanks
1. to treat Alzheimer's disease (Neuroscience and Pain)
Cerebrolysin (FPF 1070) vs Namenda (Namzaric, Memantine)
ABBV-8E12 vs Namenda (Namzaric, Memantine)
2. to treat Migraine (Neuroscience and Pain)
Depakote (valproate semisodium) vs Botox (onabotulinum A)
3. to treat Bipolar Disorder (Neuroscience and Pain)
Depakote (valproate semisodium) vs Vraylar (cariprazine)
4. to treat Parkinson’s (Neuroscience and Pain)
Duodopa (Levodopa/carbidopa) vs LTI-291
Also, if you have any market share information available for any of the above indications, please provide. Thanks
Hello, I’m looking to compare drugs for research purposes and was wondering if the following can be seen as substitutes? Why or why not? Thank you!
1. to treat Alzheimer's disease (Neuroscience and Pain)
Cerebrolysin (FPF 1070) vs Namenda (Namzaric, Memantine)
ABBV-8E12 vs Namenda (Namzaric, Memantine)
2. to treat Migraine (Neuroscience and Pain)
Depakote (valproate semisodium) vs Botox (onabotulinum A)
3. to treat Bipolar Disorder (Neuroscience and Pain)
Depakote (valproate semisodium) vs Vraylar (cariprazine)
4. to treat Parkinson’s (Neuroscience and Pain)
Duodopa (Levodopa/carbidopa) vs LTI-291
Also, if you have any market share information available for any of the above indications, please provide. Thanks
1. to treat Alzheimer's disease (Neuroscience and Pain)
Cerebrolysin (FPF 1070) vs Namenda (Namzaric, Memantine)
ABBV-8E12 vs Namenda (Namzaric, Memantine)
2. to treat Migraine (Neuroscience and Pain)
Depakote (valproate semisodium) vs Botox (onabotulinum A)
3. to treat Bipolar Disorder (Neuroscience and Pain)
Depakote (valproate semisodium) vs Vraylar (cariprazine)
4. to treat Parkinson’s (Neuroscience and Pain)
Duodopa (Levodopa/carbidopa) vs LTI-291
Also, if you have any market share information available for any of the above indications, please provide. Thanks
Brief Answer:
The new drugs need FDA approval
Detailed Answer:
Hello and welcome to Ask A Doctor service.
I am a clinical pharmacologist and will try my best to help you with required information.
There have been some preclinical and clinical trials on the new drugs mentioned in your query. I would like to tell you that many chemicals under evaluation donot get FDA approval for one reason or another. It means that they dont hit the market.
1. Alzheimers
Cerebrolysin had some clinical trials in its favor. But FDA didnot approve it.
ABBV-8E12 is still in trials.
2. Migraine
Botox is approved for chronic migraines. However its used with caution in conditions like urinary retention, compromised respiratory function, neuromuscular disorders.
Depakote also approved for migraines. Its avoided in pregnancy, kids and used in low dose in elderly.
3. Bipolar disorder
Depakote is approved for treatment of manic episodes associated with bipolar disorder
Vraylor is approved for acute treatment of manic or mixed episodes associated with bipolar I disorder
4. Parkinsons
Duodopa (Levodopa/carbidopa). Actually the name showing up is Duopa. It is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
LTI-291 is still under trials and not marketed yet.
I am not the right specialist to comment on drugs market share information.
Regarding prescription of these drugs by physicians, I can tell you that, the drus that are not approved, cannot be prescribed.
Hope this helps. Let me know if I can assist you further.
Dr Vaishalee
The new drugs need FDA approval
Detailed Answer:
Hello and welcome to Ask A Doctor service.
I am a clinical pharmacologist and will try my best to help you with required information.
There have been some preclinical and clinical trials on the new drugs mentioned in your query. I would like to tell you that many chemicals under evaluation donot get FDA approval for one reason or another. It means that they dont hit the market.
1. Alzheimers
Cerebrolysin had some clinical trials in its favor. But FDA didnot approve it.
ABBV-8E12 is still in trials.
2. Migraine
Botox is approved for chronic migraines. However its used with caution in conditions like urinary retention, compromised respiratory function, neuromuscular disorders.
Depakote also approved for migraines. Its avoided in pregnancy, kids and used in low dose in elderly.
3. Bipolar disorder
Depakote is approved for treatment of manic episodes associated with bipolar disorder
Vraylor is approved for acute treatment of manic or mixed episodes associated with bipolar I disorder
4. Parkinsons
Duodopa (Levodopa/carbidopa). Actually the name showing up is Duopa. It is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
LTI-291 is still under trials and not marketed yet.
I am not the right specialist to comment on drugs market share information.
Regarding prescription of these drugs by physicians, I can tell you that, the drus that are not approved, cannot be prescribed.
Hope this helps. Let me know if I can assist you further.
Dr Vaishalee
Above answer was peer-reviewed by :
Dr. Nagamani Ng
Brief Answer:
The new drugs need FDA approval
Detailed Answer:
Hello and welcome to Ask A Doctor service.
I am a clinical pharmacologist and will try my best to help you with required information.
There have been some preclinical and clinical trials on the new drugs mentioned in your query. I would like to tell you that many chemicals under evaluation donot get FDA approval for one reason or another. It means that they dont hit the market.
1. Alzheimers
Cerebrolysin had some clinical trials in its favor. But FDA didnot approve it.
ABBV-8E12 is still in trials.
2. Migraine
Botox is approved for chronic migraines. However its used with caution in conditions like urinary retention, compromised respiratory function, neuromuscular disorders.
Depakote also approved for migraines. Its avoided in pregnancy, kids and used in low dose in elderly.
3. Bipolar disorder
Depakote is approved for treatment of manic episodes associated with bipolar disorder
Vraylor is approved for acute treatment of manic or mixed episodes associated with bipolar I disorder
4. Parkinsons
Duodopa (Levodopa/carbidopa). Actually the name showing up is Duopa. It is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
LTI-291 is still under trials and not marketed yet.
I am not the right specialist to comment on drugs market share information.
Regarding prescription of these drugs by physicians, I can tell you that, the drus that are not approved, cannot be prescribed.
Hope this helps. Let me know if I can assist you further.
Dr Vaishalee
The new drugs need FDA approval
Detailed Answer:
Hello and welcome to Ask A Doctor service.
I am a clinical pharmacologist and will try my best to help you with required information.
There have been some preclinical and clinical trials on the new drugs mentioned in your query. I would like to tell you that many chemicals under evaluation donot get FDA approval for one reason or another. It means that they dont hit the market.
1. Alzheimers
Cerebrolysin had some clinical trials in its favor. But FDA didnot approve it.
ABBV-8E12 is still in trials.
2. Migraine
Botox is approved for chronic migraines. However its used with caution in conditions like urinary retention, compromised respiratory function, neuromuscular disorders.
Depakote also approved for migraines. Its avoided in pregnancy, kids and used in low dose in elderly.
3. Bipolar disorder
Depakote is approved for treatment of manic episodes associated with bipolar disorder
Vraylor is approved for acute treatment of manic or mixed episodes associated with bipolar I disorder
4. Parkinsons
Duodopa (Levodopa/carbidopa). Actually the name showing up is Duopa. It is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
LTI-291 is still under trials and not marketed yet.
I am not the right specialist to comment on drugs market share information.
Regarding prescription of these drugs by physicians, I can tell you that, the drus that are not approved, cannot be prescribed.
Hope this helps. Let me know if I can assist you further.
Dr Vaishalee
Above answer was peer-reviewed by :
Dr. Nagamani Ng
Dear Dr Vaishalee
This did not answer my questions unfortunately. I know where all these drugs are with clinical trials.
I just need to know if, assuming all drugs under clinical trials are FDA approved, the pairings will compete against each other. For example, beginning with #1, Alzheimer's, I need to know:
1. Assume ABBV-8E12 is FDA approved, would a doctor consider it to be a substitute and a competitor to Namenda for purposes of treating patients? I note that the two drugs treat the same indication (Alzheimer's Disease) but have different mechanisms of action.
2. Why or why not?
See below the research that we have already done:
Approved Name
(Alternate names)
Donepezil/memantine extended release
(Namzaric, Namenda, Arimenda, memantine, ADS 8703, ADS 8704)
Stage Launched
Sales ($m) $92.45m (‘20E)
Indication
Alzheimer's disease
Mechanism of Action
NMDA receptor antagonists
Companies Involved
Adamas (US): Originator
Allergan: Licensee
Description
A proprietary once daily, fixed-dose combination of memantine extended release and donepezil immediate release. Memantine is an NMDA receptor antagonist and donepezil is an acetylcholinesterase inhibitor. Designed to reduce the CNS adverse events associated with memantine and providing full strength dosing from the start of treatment. The company has improved the convenience of administration by enabling it to be sprinkled on food.
Donepezil/memantine ER has been launched in the US.
Launch, Geographic Details
Launched in US; Phase III trials also underway.
In May-15, donepezil/memantine ER was launched, following its approval in Dec-14, for the treatment of moderate to severe dementia in AD. In Jul-16, the US FDA approved the expanded label for Namenda, permitting patients with moderate to severe AD who were stabilised on monotherapy with donepezil to directly start combination therapy.
--------------------------
Approved Name
(Alternate names)
ABBV-8E12 (C2N 8E12)
Stage Phase II
Sales ($m) --
Indication
Alzheimer's disease
Mechanism of Action
Immunologic-factors, Biomodulators, Immunomodulators
Companies Involved
C2N Diagnostics (US): Originator
AbbVie: Licensee
Description
C2N 8E12, a humanised recombinant anti-human tau antibody is being developed by AbbVie and C2N Diagnostics for treatment of various neurological disorders including AD and progressive supranuclear palsy. Clinical development for the treatment of AD is ongoing in the US, Australia, Belgium, Canada, Finland, Italy, New Zealand and Spain and is underway for progressive supranuclear palsy in the US.
AbbVie, in Apr-15, entered into a worldwide licence agreement with C2N Diagnostics, to develop and commercialise a portfolio of anti-tau antibodies for the treatment of AD and other neurological disorders.
Launch, Geographic Details
Phase II in Australia, Belgium, Canada, Finland, Italy, Spain and the US.
In March 2019, AbbVie initiated a phase II extension study to evaluate the long-term safety and tolerability of C2N-8E12 for the treatment of patients with early Alzheimer's disease. In November 2018, AbbVie initiated an expanded access program to provide access to-C2N 8E12 prior to approval for patients with AD.
This did not answer my questions unfortunately. I know where all these drugs are with clinical trials.
I just need to know if, assuming all drugs under clinical trials are FDA approved, the pairings will compete against each other. For example, beginning with #1, Alzheimer's, I need to know:
1. Assume ABBV-8E12 is FDA approved, would a doctor consider it to be a substitute and a competitor to Namenda for purposes of treating patients? I note that the two drugs treat the same indication (Alzheimer's Disease) but have different mechanisms of action.
2. Why or why not?
See below the research that we have already done:
Approved Name
(Alternate names)
Donepezil/memantine extended release
(Namzaric, Namenda, Arimenda, memantine, ADS 8703, ADS 8704)
Stage Launched
Sales ($m) $92.45m (‘20E)
Indication
Alzheimer's disease
Mechanism of Action
NMDA receptor antagonists
Companies Involved
Adamas (US): Originator
Allergan: Licensee
Description
A proprietary once daily, fixed-dose combination of memantine extended release and donepezil immediate release. Memantine is an NMDA receptor antagonist and donepezil is an acetylcholinesterase inhibitor. Designed to reduce the CNS adverse events associated with memantine and providing full strength dosing from the start of treatment. The company has improved the convenience of administration by enabling it to be sprinkled on food.
Donepezil/memantine ER has been launched in the US.
Launch, Geographic Details
Launched in US; Phase III trials also underway.
In May-15, donepezil/memantine ER was launched, following its approval in Dec-14, for the treatment of moderate to severe dementia in AD. In Jul-16, the US FDA approved the expanded label for Namenda, permitting patients with moderate to severe AD who were stabilised on monotherapy with donepezil to directly start combination therapy.
--------------------------
Approved Name
(Alternate names)
ABBV-8E12 (C2N 8E12)
Stage Phase II
Sales ($m) --
Indication
Alzheimer's disease
Mechanism of Action
Immunologic-factors, Biomodulators, Immunomodulators
Companies Involved
C2N Diagnostics (US): Originator
AbbVie: Licensee
Description
C2N 8E12, a humanised recombinant anti-human tau antibody is being developed by AbbVie and C2N Diagnostics for treatment of various neurological disorders including AD and progressive supranuclear palsy. Clinical development for the treatment of AD is ongoing in the US, Australia, Belgium, Canada, Finland, Italy, New Zealand and Spain and is underway for progressive supranuclear palsy in the US.
AbbVie, in Apr-15, entered into a worldwide licence agreement with C2N Diagnostics, to develop and commercialise a portfolio of anti-tau antibodies for the treatment of AD and other neurological disorders.
Launch, Geographic Details
Phase II in Australia, Belgium, Canada, Finland, Italy, Spain and the US.
In March 2019, AbbVie initiated a phase II extension study to evaluate the long-term safety and tolerability of C2N-8E12 for the treatment of patients with early Alzheimer's disease. In November 2018, AbbVie initiated an expanded access program to provide access to-C2N 8E12 prior to approval for patients with AD.
Dear Dr Vaishalee
This did not answer my questions unfortunately. I know where all these drugs are with clinical trials.
I just need to know if, assuming all drugs under clinical trials are FDA approved, the pairings will compete against each other. For example, beginning with #1, Alzheimer's, I need to know:
1. Assume ABBV-8E12 is FDA approved, would a doctor consider it to be a substitute and a competitor to Namenda for purposes of treating patients? I note that the two drugs treat the same indication (Alzheimer's Disease) but have different mechanisms of action.
2. Why or why not?
See below the research that we have already done:
Approved Name
(Alternate names)
Donepezil/memantine extended release
(Namzaric, Namenda, Arimenda, memantine, ADS 8703, ADS 8704)
Stage Launched
Sales ($m) $92.45m (‘20E)
Indication
Alzheimer's disease
Mechanism of Action
NMDA receptor antagonists
Companies Involved
Adamas (US): Originator
Allergan: Licensee
Description
A proprietary once daily, fixed-dose combination of memantine extended release and donepezil immediate release. Memantine is an NMDA receptor antagonist and donepezil is an acetylcholinesterase inhibitor. Designed to reduce the CNS adverse events associated with memantine and providing full strength dosing from the start of treatment. The company has improved the convenience of administration by enabling it to be sprinkled on food.
Donepezil/memantine ER has been launched in the US.
Launch, Geographic Details
Launched in US; Phase III trials also underway.
In May-15, donepezil/memantine ER was launched, following its approval in Dec-14, for the treatment of moderate to severe dementia in AD. In Jul-16, the US FDA approved the expanded label for Namenda, permitting patients with moderate to severe AD who were stabilised on monotherapy with donepezil to directly start combination therapy.
--------------------------
Approved Name
(Alternate names)
ABBV-8E12 (C2N 8E12)
Stage Phase II
Sales ($m) --
Indication
Alzheimer's disease
Mechanism of Action
Immunologic-factors, Biomodulators, Immunomodulators
Companies Involved
C2N Diagnostics (US): Originator
AbbVie: Licensee
Description
C2N 8E12, a humanised recombinant anti-human tau antibody is being developed by AbbVie and C2N Diagnostics for treatment of various neurological disorders including AD and progressive supranuclear palsy. Clinical development for the treatment of AD is ongoing in the US, Australia, Belgium, Canada, Finland, Italy, New Zealand and Spain and is underway for progressive supranuclear palsy in the US.
AbbVie, in Apr-15, entered into a worldwide licence agreement with C2N Diagnostics, to develop and commercialise a portfolio of anti-tau antibodies for the treatment of AD and other neurological disorders.
Launch, Geographic Details
Phase II in Australia, Belgium, Canada, Finland, Italy, Spain and the US.
In March 2019, AbbVie initiated a phase II extension study to evaluate the long-term safety and tolerability of C2N-8E12 for the treatment of patients with early Alzheimer's disease. In November 2018, AbbVie initiated an expanded access program to provide access to-C2N 8E12 prior to approval for patients with AD.
This did not answer my questions unfortunately. I know where all these drugs are with clinical trials.
I just need to know if, assuming all drugs under clinical trials are FDA approved, the pairings will compete against each other. For example, beginning with #1, Alzheimer's, I need to know:
1. Assume ABBV-8E12 is FDA approved, would a doctor consider it to be a substitute and a competitor to Namenda for purposes of treating patients? I note that the two drugs treat the same indication (Alzheimer's Disease) but have different mechanisms of action.
2. Why or why not?
See below the research that we have already done:
Approved Name
(Alternate names)
Donepezil/memantine extended release
(Namzaric, Namenda, Arimenda, memantine, ADS 8703, ADS 8704)
Stage Launched
Sales ($m) $92.45m (‘20E)
Indication
Alzheimer's disease
Mechanism of Action
NMDA receptor antagonists
Companies Involved
Adamas (US): Originator
Allergan: Licensee
Description
A proprietary once daily, fixed-dose combination of memantine extended release and donepezil immediate release. Memantine is an NMDA receptor antagonist and donepezil is an acetylcholinesterase inhibitor. Designed to reduce the CNS adverse events associated with memantine and providing full strength dosing from the start of treatment. The company has improved the convenience of administration by enabling it to be sprinkled on food.
Donepezil/memantine ER has been launched in the US.
Launch, Geographic Details
Launched in US; Phase III trials also underway.
In May-15, donepezil/memantine ER was launched, following its approval in Dec-14, for the treatment of moderate to severe dementia in AD. In Jul-16, the US FDA approved the expanded label for Namenda, permitting patients with moderate to severe AD who were stabilised on monotherapy with donepezil to directly start combination therapy.
--------------------------
Approved Name
(Alternate names)
ABBV-8E12 (C2N 8E12)
Stage Phase II
Sales ($m) --
Indication
Alzheimer's disease
Mechanism of Action
Immunologic-factors, Biomodulators, Immunomodulators
Companies Involved
C2N Diagnostics (US): Originator
AbbVie: Licensee
Description
C2N 8E12, a humanised recombinant anti-human tau antibody is being developed by AbbVie and C2N Diagnostics for treatment of various neurological disorders including AD and progressive supranuclear palsy. Clinical development for the treatment of AD is ongoing in the US, Australia, Belgium, Canada, Finland, Italy, New Zealand and Spain and is underway for progressive supranuclear palsy in the US.
AbbVie, in Apr-15, entered into a worldwide licence agreement with C2N Diagnostics, to develop and commercialise a portfolio of anti-tau antibodies for the treatment of AD and other neurological disorders.
Launch, Geographic Details
Phase II in Australia, Belgium, Canada, Finland, Italy, Spain and the US.
In March 2019, AbbVie initiated a phase II extension study to evaluate the long-term safety and tolerability of C2N-8E12 for the treatment of patients with early Alzheimer's disease. In November 2018, AbbVie initiated an expanded access program to provide access to-C2N 8E12 prior to approval for patients with AD.
Brief Answer:
Described below
Detailed Answer:
Alzheimers
1. If ABBV-8E12 is FDA approved, still a doctor will not consider it to be a substitute and a competitor to Namenda for purposes of treating patients. He will most probably give this medicine to resistant cases where Namenda is unsuccessful. It can also be used as add-on therapy to existent medicines for short term.
2. Because of its serious side effects that it may have in some people like hypersensitivity.
Migraine
Botox and Depakote can compete with each other despite different mechanism of actions, due to same indication.
Bipolar disorder
Depakote and Vraylor can compete with each other for same indication.
Parkinsons
Duopa and LTI-291 cannot compete due to different mechanisms. Duopa will be prefered and LTi-291 maybe added for later stages.
Dr Vaishalee
Described below
Detailed Answer:
Alzheimers
1. If ABBV-8E12 is FDA approved, still a doctor will not consider it to be a substitute and a competitor to Namenda for purposes of treating patients. He will most probably give this medicine to resistant cases where Namenda is unsuccessful. It can also be used as add-on therapy to existent medicines for short term.
2. Because of its serious side effects that it may have in some people like hypersensitivity.
Migraine
Botox and Depakote can compete with each other despite different mechanism of actions, due to same indication.
Bipolar disorder
Depakote and Vraylor can compete with each other for same indication.
Parkinsons
Duopa and LTI-291 cannot compete due to different mechanisms. Duopa will be prefered and LTi-291 maybe added for later stages.
Dr Vaishalee
Above answer was peer-reviewed by :
Dr. Chakravarthy Mazumdar
Brief Answer:
Described below
Detailed Answer:
Alzheimers
1. If ABBV-8E12 is FDA approved, still a doctor will not consider it to be a substitute and a competitor to Namenda for purposes of treating patients. He will most probably give this medicine to resistant cases where Namenda is unsuccessful. It can also be used as add-on therapy to existent medicines for short term.
2. Because of its serious side effects that it may have in some people like hypersensitivity.
Migraine
Botox and Depakote can compete with each other despite different mechanism of actions, due to same indication.
Bipolar disorder
Depakote and Vraylor can compete with each other for same indication.
Parkinsons
Duopa and LTI-291 cannot compete due to different mechanisms. Duopa will be prefered and LTi-291 maybe added for later stages.
Dr Vaishalee
Described below
Detailed Answer:
Alzheimers
1. If ABBV-8E12 is FDA approved, still a doctor will not consider it to be a substitute and a competitor to Namenda for purposes of treating patients. He will most probably give this medicine to resistant cases where Namenda is unsuccessful. It can also be used as add-on therapy to existent medicines for short term.
2. Because of its serious side effects that it may have in some people like hypersensitivity.
Migraine
Botox and Depakote can compete with each other despite different mechanism of actions, due to same indication.
Bipolar disorder
Depakote and Vraylor can compete with each other for same indication.
Parkinsons
Duopa and LTI-291 cannot compete due to different mechanisms. Duopa will be prefered and LTi-291 maybe added for later stages.
Dr Vaishalee
Above answer was peer-reviewed by :
Dr. Chakravarthy Mazumdar
Answered by
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