Pharmacological treatment of disorders affecting the central nervous system (CNS) is a complex task. Different parameters may negatively influence effective targeting of the CNS and drug compliance, for example, poor brain-blood barrier (BBB) permeability, patient forgetfulness or neglect, and lack of collaboration between caregivers and patients. Pharmaceutical science is constantly looking for new administration strategies for efficient drug delivery to the CNS that could obviate these problems. Drugs can reach the brain through the skin, nasal cavity and oral cavity, and while effective transport of drugs from skin and nasal cavity to the CNS has been documented, these studies did not stimulate the introduction of a substantial number of new drug formulations to treat CNS disorders. Nasal drug delivery, generally used to administer locally acting molecules, is not common for systemic administration, although the possibility and importance of such systemic administration is suggested by several studies. This paper reviewed different anatomical and pharmaceutical factors related to drug administration through the nasal route, and explored whether nasal delivery of selected CNS drugs could improve their pharmacokinetics and patient compliance. This route offers attractive advantages, and pharmaceutical scientists and anatomists should collaborate to improve CNS drug compliance and to increase the number of compounds that can be administered intranasally.
[PubMed - indexed for MEDLINE
Just an observation regarding the EMA medicines under evaluation. I cannot see a single application in the last month or two in relation to CNS drugs such as ours. If I recall correctly Memantine another NMDA drug was the last to go though.
Several things come to mind not limited to, the shortage in development of better drugs.
Have a pleasant day all. Probably our turn for a good one, lets see what delights today brings.
Good morning Jean ;-)
Hope all is well with you. It is getting to be a long trip for you also, good on you staying the course.
Hello Horcents my friend – First and for most I do hope you are doing ok.
I also wish to thank you for your kind words pointed in my direction in another thread, they are much appreciated.
Very best regards.
Hi Ray Thank you for your reply
“My opinion is that dex/quin should be used for pain, ahead of opiates, and at a dose that works, like 40 dex/20 quin twice per day, not a dose that does not work like 20 dex/10 quin twice per day.
This strikes me as straightforward, logical reasoning which should not be confusing to anyone”
What may be confusing to some is that you were waiting for of label pain use and was wondering why you had not heard much about that, at the same time stating that the 20/10 dose will probably does not work. I will rephrase the last bit, you are now stating that it does not work.
In my previous post I left in your comment “Also, the potential for ventricular arrhythmia due to a quinidine dose that prolongs the QT interval is a real concern and can not be dismissed”. Having left this in due to the fact that I was all but sure you would come back with your 40dex/20 quin dose. This may also be confusing to some as in you highlight the prolongation of the QT interval as a real concern yet you effectively are doubling up on the quin.
I thought you would be pleased to hear Dr Wyn success with N for pain after waiting all that time to hear about pain use, apparently not.
I would not be surprised that we get to see more on the board about the QT interval after the anticipated patent challenge success as there is not much left to go at now. Then we have the DDM to consider.
IMO Rohan is no slouch.
Previous SEC Records
Acquisition (Non Open Market) direct 63,000 Shares Held 123,000
All is in order and more so ;-)
Hi Again Riside sorry to harp on.
As I see it Rohan does not get a look in at the Trading Plans as far as I can tell. In that respect he would be the one I would pick out to monitor regarding insider trades.
If we were to look at Rohan transactions, as far as I can see he has only ever bought shares.
On the Nasdaq I’m seeing KK SEC Form 4 as follows.
Form 4 SEC Date of Earliest Transaction 11/01/2013
4385 Shares sold at 4.1363 The sales reported on this Form 4 were effected pursuant to a trading plan adopted pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended. The proceeds from the sale will be used to pay required tax withholdings due upon the vesting of Restricted Stock Units granted to the Reporting Person.
Usual thing trading plan. Not particularly good timing this time round for KK he will not worry due to he can replace them on the cheap
The other SEC Form 4 I see Rohan buying 10,000 shares. 11/4/2013
Hope you are well.
Good morning Winkles.
It is pretty crowded behind the curtain at the minute.
The boards entertainment value just gets better and better one of my favorite posts of the past being the Black limo, (no offence Harry).
Enjoy your day my friend.
Hello Ray – Now there could be a very good reason for that, you will recall Onlyfacts
bringing this to our attention back in June if I recall correctly. Perhaps it is another case like you suggested in the past where it is already priced in.
Hi Frank always good to hear from you.
You are welcome; I cannot accept full responsibility for the good fortunes regarding SSPI, as with most good leads one has to have a trusted source. One of our absent old timers Tartia mentioned it a good while back to Sarge and it developed from there.
I’m glad you are doing well.
Very best regards.
I thought you may have been pleased regarding Dr Wyn using N for pain. I remember when you first arrived on the board, you stated you were waiting for off label pain. That being despite your good self stating below it is unlikely to relieve pain. Some may find this confusing, others will find it self explanatory.
“Sorry to rain on the parade here but dex 20, quin 10 once or twice a day is unlikely to be relieving pain, based on the subset of the STAR study and based, as I recall, on diabetic neuropathic pain studies.
Also, the potential for ventricular arrhythmia due to a quinidine dose that prolongs the QT interval is a real concern and can not be dismissed.”
You may note I have left the last sentence in.
Just going to lunch Mikie
If I did not have to drive to today’s venue I would have a glass of wine, what with all today’s revelations.
Very fitting you bought this thread forward before we got to read Dr Wyn’s statement regarding using N to replace several drugs as documented in the patent litigation records. It is a substantiated start.
Cheers for now.
You have informened us on much this morning, and highlighted a great deal. Needless to say the information is substantiated as is in the proceedings. The extracted words from Dr Wyn below, IMO mean a tremendous amount. Over the years I have harped on until I’m past being blue in the face regarding the merits of a multi use drug, I see this as substantiation of the same.
Here we have N replacing a number of drugs, which in turn reduces costs, side effects and , interactions just to name a few benefits. At last At last loud and clear.
“He then says that if a patient is on 3-4 different meds, he will take them off of all but N, because it has the least number of side effects...”
One of the best days if not the best day regarding news of our drug since the initial approval.
As you may guess I’m over the moon.
Just want to express my appreciation of all the hard work and research you have done regarding the patent litigation. Your tireless efforts are much appreciated with respect of keeping us all up to date on this immensely important aspect.
You probably will not, but take a well earned rest after your brilliant posting of this morning.
I look forward to sharing the much anticipated rewards in the not to distant future with your good self.
Very best regards and thank you again.
Good morning Mikie
Needless to say you are more than welcome.
Since the start of this thread a great deal has been uncovered. I for one will be seeing this out. Having said that much, much more will be revealed regarding the capabilities of the drug other than what is contained in the thread to date. I say it again I was over the moon with the additional information gained during the first investor day presentation.
A little bit of food for thought, although Joao disclosed a great deal, not for one minute do I think the full hand was shown.
Have a most enjoyable day Mikie.
Good morning Placesontherun.
Thank you for continuing to keep us up to date.
Part 2 of 2
Quality-by-design is a science and risk-based approach to pharmaceutical development and manufacturing. It involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.
The document published today focuses on ‘design space verification’, a demonstration that the combination of the process parameters and material attributes established at pilot scale during pharmaceutical development are capable of delivering a product of appropriate quality on a commercial scale.
In March 2011, the EMA and US FDA launched a three-year pilot programme for the parallel assessment of certain quality or chemistry manufacturing and control (CMC) sections of applications that are relevant to quality-by-design. With the agreement of the applicants, experts from the Japanese (PMDA) participate as observers in the programme.
The objective of the parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the quality-by-design concept and promote the availability of medicines of consistent quality throughout the European Union (EU) and the USA.
The question-and-answer document published today reflects the conclusions reached by the EU and US regulators on the specific topic of design space verification as part of their parallel assessment.
The EMA and the US FDA will publish further conclusions on other quality-by-design-related topics as the pilot programme continues and more parallel assessments are conducted.
The pilot programme is open to selected procedures, including applications for initial marketing authorisations, type-II variations and scientific advice.
Participation in the pilot is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.
Good night all
Part 1 of 2
European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach
The (EMA) and the US FDA) have published a second joint question and answers document that provides guidance on the quality-by-design concept.
You will find this wording below “The pilot programme is open to selected procedures, including applications for initial marketing authorisations, type-II variations and scientific advice”
You may also recall that I have posted about the EMA variations in the past. If you cannot recall the same the EMA variation system is basically an indication add on path way using the original approved drug data. One of our competitors drugs Memantine recently used this route in a speedy manner to gain approval for further indications in relatively rapid order.
I have only just got wind of the update so I have not studied it in depth, never a less I’m greatly encouraged that the EMA and the FDA are working close on this aspect ( Note Japan are now sitting in). With the future developments of Avanir in mind as mentioned in the recent investors day one would hope that the collaboration will be of great benefit to our growing company.