Absolutely nothing on stroke. It must not be important in the neurology world to solve any of the problems in stroke. I blame our fucking failures of stroke associations for just putting out 'happy talk' rather than working to solve all the real life failures in stroke. With NO strategy nothing will ever get fixed.
http://www.medpagetoday.com/Neurology/GeneralNeurology/62121?xid=nl_mpt_DHE_2016-12-17&
The neurology community may be ending the year on a low note, with
the failed phase III trial of solanezumab in mild Alzheimer's disease.
On the other hand, many are hopeful that there will be a new treatment
for primary progressive multiple sclerosis before the year is out, as
ocrelizumab (Ocrevus) is poised to become the first treatment for PPMS
-- as long as the FDA approves that indication, as its benefits in
relapsing MS have been clearer.
In the case of solanezumab, the drug failed to meet its primary endpoint in EXPEDITION3,
results from which were presented at the Clinical Trials in Alzheimer's
Disease (CTAD) meeting in San Diego. There was an 11% slower decline in
disease progression for those on the drug compared with placebo, but
the difference on the ADAS-Cog14 wasn't significant at 80 weeks. Some
secondary endpoints favored solanezumab, but given the lack of an effect
on the primary cognitive endpoint, Lilly decided not to pursue an
indication in mild to moderate disease.
Many
in the field were concerned that the findings would spell the end for
the amyloid hypothesis, but that's not how lead researcher Paul Aisen, MD, of the University of Southern California in Los Angeles, saw it.
"This is not a refutation of the amyloid hypothesis," Aisen said at
the meeting. "I think this is a confirmation of the amyloid hypothesis. I
think it is the strongest confirmation to date."
Not everyone agreed with him. "I don't think [the findings] dispute it, and I don't think they necessarily affirm it either," Anton Porsteinsson, MD, of the University of Rochester in Rochester, N.Y., told MedPage Today at the CTAD meeting.
One other finding presented at the CTAD meeting came as a boon to the
amyloid hypothesis. Biogen presented positive data on its anti-amyloid
candidate aducanumab. Following concerns about ARIA,
Biogen added a titration arm to the phase Ib PRIME study, and this
group had less ARIA and good efficacy when compared with a steady higher
dose of the drug.
While solanezumab targets insoluble amyloid fibrils, aducanumab
scavenges soluble forms of the protein -- so the difference in
mechanism may account for the better results. Yet, researchers are
cautious, as a lot can change between phase I and phase III.
In short, the field isn't ready to let go of the amyloid hypothesis just yet.
Good News for PPMS?
Experts in MS are banking on a randomized controlled trial that showed a 24% lower risk of progression
with ocrelizumab over placebo to win FDA approval for an indication in
progressive disease. This would be the first drug ever approved for this
more aggressive form of the disease, and clinicians are eager to have
something official to offer their patients.
In the meantime, some are looking to a very similar drug to ocrelizumab to treat this population. Rituximab
(Rituxan) is also an anti-CD20 monoclonal antibody, and it's made by
the same company that developed ocrelizumab (Roche-Genentech). It will
be a cheaper alternative to its on-patent cousin, and some centers,
including one in Denver and another in Sweden, are already using it regularly for their progressive MS patients.
Controversy, Cannabidiol, CARA
The controversial approval of eteplirsen
for Duchenne muscular dystrophy also dominated headlines in neurology
in 2016. The decision revealed infighting within the FDA, which was
under enormous public pressure to approve the drug, given vocal outcries
from patient advocacy groups.
Although Janet Woodcock, MD,
director of the FDA's Center for Drug Evaluation and Research, was in
favor of approval, many within the agency felt the data just weren't
strong enough to support that conclusion. An FDA advisory panel earlier in the year was similarly split on its conclusions about eteplirsen.
In other news, eyes are on a pharmaceutical-grade cannabidiol product
that appears to have efficacy in two rare seizure disorders. Drugmaker
GW Pharmaceuticals presented positive findings from a trial in Lennox-Gastaut, and another in Dravet Syndrome, at the American Epilepsy Society meeting. The company says it hopes to submit a new drug application (NDA) to the FDA in mid-2017.
And for yet another year, the opioid crisis continued to make headlines, with a new law -- the Comprehensive Addiction and Recovery Act (CARA) -- that expanded medication-assisted treatment and access to treatment programs. There were also new opioid guidelines from the CDC; an opioid "action plan" from the FDA; a landmark report on addiction from the U.S. Surgeon General; and an increase in the number of patients a doctor can treat with buprenorphine (the U.S. Department of Health and Human Services bumped the cap from 100 to 275).
Here are more of this year's top headlines:
Aisen: Negative Study Confirms Amyloid Hypothesis
Cannabidiol Works in Dravet, Lennox-Gastaut
More Evidence of Dementia Decline
Brain Implant Helps Locked-In Patient Communicate
Amyloid Scans Change Dementia Diagnoses
FAAH Trial Neurologic Effects Detailed
Second Thoughts About Memory Complaints
Surgeon General: Addiction Not a 'Moral Failing'
FDA Splits on Naloxone Dose
Siponimod May Slow Worsening in SPMS
Opioid Bill Overwhelmingly Approved by Senate
Eteplirsen OK'd for Muscular Dystrophy
Novel Agent Works in Primary Progressive MS
First Amyloid, Then Tau, Then Dementia
FDA Says Yes to Focused Ultrasound for Tremor
Blast TBI May Do Distinct Damage in Brain
Biogen's Monthly MS Injection Wins Approval
FDA Okays Pimavanserin for Hallucinations in Parkinson's
HHS Awards $53 Million to Fight Opioid Abuse Epidemic
FDA Chief Criticizes Industry for Inaction on Opioids
HHS Eases Buprenorphine Prescribing
Implant for Opioid Addiction Wins FDA Approval
CDC Comes Down Hard on Opioids for Chronic Pain
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