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Thanks & good to know this.
Is there any trial related to this that I can read about?
I try to google it & not much luck.
Science literature is too much for me to understand.
DXM part of AXS-05,
People build up tolerance with frequent DXM use.
According to MDD P2 topline data, it is measured at 6 weeks.
It would be interest to know how long AXS-05 works for MDD & how to tape off once a remission is confirmed.
I suppose once the safety trial concludes, the company should have that type of data as well.
Last sentence of:
"I do think the planned MDD phase 3 trial has a higher chance to succeed based on the P2 data as P2 is with comparator arm (Wellbutrin) vs P2 is with placebo. "
Should be like this:
I do think the planned MDD phase 3 trial has a higher chance to succeed based on the P2 data as P2 is against active (Wellbutrin) comparator arm vs P3 is against placebo.
Thanks for the info.
Do you believe STRIDE-1 topline readout push back is due to AXSM want to additional patients to satisfy safety data (300 patients total 200 for at least one year & 100 for at least two year)?
I thought the safety trial is open label.
I do think the planned MDD phase 3 trial has a higher chance to succeed based on the P2 data as P2 is with comparator arm (Wellbutrin) vs P2 is with placebo.
I asked them
1) why STRIDE-1 topline result is being delayed?
2) is the data still blind or not?
I will post if they respond.
I send an email to the company.
Hope they respond.
I would agree with TRD is difficult to treat.
I also wonder why STRIDE-1 topline readouts being pushed back a few times.
I am ok if the trial result is still blinded.
But how do we know?
CORRECTION: $17B is annual global revenue per the article.
The link below has some numbers on depression & antidepressant cost.
http://time.com/4900248/antidepressants-depression-more-common/
"As TIME reported in a recent cover story, clinical depression affects about 16 million people in the U.S. and is estimated to cost the U.S. about $210 billion a year in productivity loss and health care needs. Global revenue for antidepressants is projected to grow to nearly $17 billion by 2020."
IF AXS-05 is as effective as ASCEND trial plus prove to be safe long term, it should take a % out of 17B projected annual US market.
The company had 1% estimate a while back for TRD (before MDD ASCEND readout).
I also would like to add that timeline for AXS-05 to play out is quite quick which is a plus.
So it does not take too long to know if AXSM is for real or not.
I think it will all depends on clinical development.
1) AXS-05
a) STRIDE-1 for TRD 2H 2019,
b) MDD phase 3 still yet to start but 2H 2019 readout,
c) Safety data which is an important aspect.
2) AXS-12 Phase 2 readout 1H 2019.
3) AXS-07 for migraine Phase 3 readout 2H 2019.
IF AXS-05 has no safety issue, and TRD readout is positive, this one alone could take the market cap a few times higher than it is today.
BUT this is biotech & it is impossible to predict trial results.
AXS-12 info.
I was looking at 5/13 cooperation presentation.
Page 26 has patents protections for various program.
Anyone know what is the similar info for AXS-12?
Thanks in advance.
Thanks Due,
I have someone very close to me has TRD.
I personally feel the effect of this.
I hope AXS-05 would work or any meds for that matter.
This is the current AXS-12 p2 study info.
https://clinicaltrials.gov/ct2/show/NCT03881852
Study Design:
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019
Outcome Measurement
1) Primary Outcome Measures :
Number of cataplexy attacks [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
Secondary Outcome Measures :
1) Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
The ESS is a patient-reported questionnaire consisting 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score can range from 0 to 24.
2) Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
I was looking at AXS-12 (reboxetine) for narcolepsy.
Here is the pilot study I find by googling it.
https://www.ncbi.nlm.nih.gov/pubmed/11322710
The article is dated 2001.
Abstract
STUDY OBJECTIVES:
To investigate potential stimulant and anticataplectic effects of 10 mg reboxetine in patients diagnosed with narcolepsy.
DESIGN:
12 patients were treated for a 2-week period with 10 mg reboxetine under open conditions. The dosage of reboxetine was gradually increased between Day 1 and Day 9. Outcome parameters consisted of nightime polysomnography (PSG), Multiple Sleep Latency Test (MSLT), Epworth Sleepiness Scale (ESS), Visual Analog Scale for Sleepiness (VAS), Ullanlinna Narcolepsy Scale (UNS), and the Beck Depression Inventory (BDI).
SETTING:
Sleep Disorders Clinic at a University Hospital.
PATIENTS:
12 patients meeting ICSD-criteria for narcolepsy.
INTERVENTIONS:
Pharmacological treatment with reboxetine.
RESULTS:
Following treatment for two-weeks, a significant improvement in daytime sleepiness could be observed, as reflected by a mean decrease of 48.6% on the Epworth Sleepiness Scale and a mean increase of 54.7% in sleep latency on the MSLT. Furthermore, a significant reduction in the cataplexy subscore of the Ullanlinna Narcolepsy Scale and in REM-sleep was found.
CONCLUSIONS:
Our results suggest that reboxetine exerts stimulant and anticataplectic effects in narcolepsy. Contrary to previous thinking, by which stimulant action would require dopaminergic facilitation, noradrenergic mechanisms might be relevant to the control of wakefulness.
DD,
What about AXS-05 for MDD?
"Breakthrough Therapy Meeting Outcomes:
Completed ASCEND trial in MDD, now considered as pivotal, is sufficient with the ongoing STRIDE-1 trial in TRD, if positive, to support an NDA filing for AXS-05 for the treatment of MDD.
A placebo-controlled Phase 3 trial in MDD, if positive, in conjunction with the completed ASCEND trial may also support an NDA filing for AXS-05 in the treatment of MDD.
A safety database of MDD and TRD patients totaling at least 300 patients treated with AXS-05 for at least six months and at least 100 patients treated for one year is required for the NDA filing. Patients completing the ongoing STRIDE-1 and the planned placebo-controlled Phase 3 MDD trials will enter an open-label safety extension trial to build the required safety database.
A TRD indication may be supported by a placebo-controlled Phase 3 trial in TRD, if positive, in conjunction with the ongoing STRIDE-1 trial, if positive, and the completed ASCEND trial."
https://www.globenewswire.com/news-release/2019/05/06/1817271/0/en/Axsome-Therapeutics-Announces-Expedited-Development-and-Pivotal-Status-for-AXS-05-in-the-Treatment-of-Major-Depressive-Disorder-based-on-FDA-Breakthrough-Therapy-Meeting.html
I am surprised that the board is so quiet with the strength this company has shown since Jan. stock price wise & products development wise.
On top of a lot good developments, I do have the following reservations.
AXS-07 40% of 875 subjects randomized in little over one month period.
Is this too good to be true?
AXS-05 for TRD phase 3 topline readout pushed twice (1Q19 to 2Q19 & now 2H19).
AXS-12 phase 2 topline readout risk.
I am long & would like to be longer.
Any answers to the above would be appreciated.
The move from 1Q20 to 2H19 is the MOMENTUM trial of AXS-07 for migraine.
The move from 2Q19 to 2H19 STRIDE-1 trial is of AXS-05 for TRD.
so The STRIDE-1 topline result will be pushed back from 2Q19 to 2H19?
There is little more info about J&J TRD spray.
https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
"Patients start out with one month of treatment twice a week for a cost of $4,720 to $6,785—before discounts depending on dose, a J&J spokeswoman said. Afterwards, those who respond move receive treatment either weekly or every other week. Spravato's monthly cost after the first month ranges from $2,360 to $3,540."
Looks like TRD is a BIG market.
While we wait for TRD readout, I find this newly approved TRD drug.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632761.htm
I like to get some update on their SARM program partnership.
It has been three month since last time they mentioned progress well.
That patent Craig filed long time ago is only for printing money for himself .
I plan to hold through 12/7 deadline without doing anything.
I expect to receive $1.52 for each ocrx share plus one CVR.
I don't expect to see any changes of the deal.
It is still at little over $100M market cap.
As long as the data continue to show promising, the market cap should rise steadily. A big pharma partner should also help.
OCRX to be acquired by Mallinckrodit for $1.52/share.
Ladeburg on TRIL on ASH
http://www.twitlonger.com/show/n_1sq9j5k
(from twitter @jayabacus)
If the stock up 100% in a very short period of time, it is just the right thing to do to raise additional money regardless if they can find a partner or not.
It may still open for trade after hour today.
i would guess $12.
will dvax open for trade today?
Most of the companies stocks (if not all) are halted on the day of adcom.
If you have time, you can watch adcom live.
https://collaboration.fda.gov/vrbpac072817/
option expiration day.
Every one of my bio stocks are down except tril.
Noticed yesterday a sudden volume increase to about 50k during the midday.
This is 2013 news?
In this quarterly release, TRIL stated that the company intend to advance TTI-622, into clinical testing with the filing of an IND submission by the end of 2017.
This may signal TTI-621 may not as effective as the company has hoped.
TRIL first quarter report.
https://finance.yahoo.com/news/trillium-reports-first-quarter-2017-110000630.html
What if NVS does not exercise the option?
what happens if the next result is not "so great"?
Feels like a secondary in the works.
Is this comments from Dr. Robert S. Rahimi coming out today?
Thanks