Author Topic: TGA proposes to schedule Phenibut as S9 (banned, no medical use)  (Read 1037 times)

Offline Chip (OP)

  • Server Admin
  • Hero Member
  • *****
  • Administrator
  • *****
  • Join Date: Dec 2014
  • Location: Australia
  • Posts: 5588
  • Reputation Power: 0
  • Chip has hidden their reputation power
  • Gender: Male
  • Last Login:Today at 01:45:53 AM
  • Deeply Confused Learner
TGA proposes to schedule Phenibut as S9 (banned, no medical use)
« on: September 24, 2017, 09:04:58 AM »
2.3. Phenibut Referred  scheduling  proposal

A delegate  from  the  Therapeutic  Goods  Administration  has  referred  a  scheduling  proposal  to  create a new Schedule  9  or  Schedule  4  with an  Appendix  D, Part  5  entry  for  phenibut  in  the  Poisons  Standard. Scheduling  application This was a  delegate  initiated  application.

 The  delegate’s  proposed  amendments  to the  Poisons Standard  are: Schedule  9  –  New  Entry PHENIBUT. OR Schedule  4  – 
New  Entry PHENIBUT. Appendix  D,  Part  5  –  New  Entry PHENIBUT. AND Index  – 
New  Entry PHENIBUT cross  reference:  BETA-PHENYL-GAMMA-AMINOBUTYRIC ACID Schedule  4/9 Appendix D,  Part  1

The  reasons  for  the  request  are:

•  Case reports  of  significant  toxicity  have  emerged, as  well  as  evidence  of  dependence;  and
•  One state  has  raised  concerns  regarding  the  potential  for  tolerance  and  withdrawal  symptoms  from the  use  of  Phenibut.

Specific  toxicity  is  related  to these  symptoms. Current  scheduling  status  and  relevant  scheduling  history Phenibut  is  currently  not  captured  by  any  schedule  entry  in  the  current  Poisons Standard.

The  pharmacologically  similar  substance,  Baclofen, is  in  Schedule  4  and  Appendix  K  of  the  current Poisons Standard. Phenibut  has  not  been  previously  considered  for  scheduling. Therefore, a  scheduling  history  is  not available. Australian regulatory  information Phenibut  is  not  listed  as an  ingredient  in  products  on  the  ARTG  and  cannot  be legally  sold  in  Australia as  a  Therapeutic  Good.

However,  information  received  from  one  Australian  state  health department indicates that  phenibut  is marketed  to relieve  anxiety  and  depression, improve  sleep  and  enhance cognition. Despite  phenibut  not  being  in  products  on  the  ARTG, the  Database  of  Adverse  Events  Notification (DAEN) - Medicines  has  returned  1  report  of  an  adverse  event  suspected  to be  related  to  phenibut  in an  unregistered  product. Phenibut  is  not  listed  in  the  Therapeutic  Goods  (Permissible  Ingredients)  Determination  No. 3  of  2017.

International  regulations No evidence  of  scheduling  in  New  Zealand,  EMA,  US  FDA  or  Canada. Substance  summary Phenibut  is  a  neuropsychotropic  drug  with anxiolytic  and  nootropic  (cognition  enhancing)  effects.

It acts as a  GABA  mimetic,  primarily  at  GABAB  and  to some  extent  at  GABAA  receptors.

Table  2.3.1:  Chemical  information  for  phenibut Property Phenibut Chemical  structure Molecular  formula C 10 H 13 NO 2 Molecular  weight 179.2 CAS  number 1078g/mol 213 Delegates’ interim  decisions  and reasons  for  decisions September  2017.

Eleven  (11)  public  submissions  were  received, two (2)  in  support, eight  (8)  opposed  (four  (4)  to the Schedule  9  proposal  and  four  (4)  showing  some  agreement  with a  Schedule  4  entry  to allow  access via a  prescription)  and  one  (1)  did  not  state  their  position.

Main points  in support:

•  There are no established  therapeutic  uses  for  phenibut.

•  In Australia  there  are  confirmed  cases  of  phenibut  poisoning  and  an  increase  in  the  number  of suspected  cases  of  phenibut  use, misuse  and  harm.

•  Phenibut  is  marketed  on  the  internet  as  a  dietary  supplement  to treat  anxiety  and  sleep  disorders. However,  there  is  strong  evidence  to indicate  that  it  is  predominantly  used  as  a  recreational  drug. •  The medical  conditions  phenibut  is  reportedly  being  used  to treat  (including  anxiety  and  sleep disorders)  are  better  managed  by  a  medical  practitioner.

•  Phenibut  represents  a  significant  risk  of  harm, including  overdose  (intentional  and  accidental). Complications  of  overdose  include  coma  requiring  admission  to an  Intensive  Care  Unit  (ICU)  for advanced  life  support. •  Withdrawal symptoms result  when  phenibut  is  stopped.

•  No preference  between  Schedule  4/Appendix  D  or  Schedule  9  was  indicated  in  the  submissions. Main  points  opposed:

•  Personal stories  indicate  that  where  other  medicines  have  failed  phenibut  has: –  provided  improvement  to sleep  and  symptoms  of  anxiety, depression, idiopathic  hypersomnia and  Post-Traumatic  Stress  Disorder  (PTSD);  and   –  been used  to treat  addiction  to alcohol  and  benzodiazepine  use. •  Claims that  suppliers  of  phenibut  provide  adequate  information  on  its  safe  use.

•  Consumers have had  no problems  with toxicity  or  dependence  and  believe  phenibut  is  very  safe. •  Scheduling  phenibut  may  cause  an  increase  in  alcohol  consumption, use  of  stronger  anti-anxiety medicines  or  black-market  drug  purchasing.

•  Internationally  phenibut  is  only  regulated  in  Russia. No evidence  for  scheduling  in  other  countries.

•  Submissions  indicate  some  preference  for: –  Schedule  4 without  an  appendix  entry  to  allow  access  via a prescription;  and –  Schedule  3  to  allow  access  by  a pharmacist. The  public  submissions  will  be  made  available  on  the  TGA  website.

Summary of  ACCS-ACMS advice  to  the  delegate The committee  recommended  that  new  Schedule  9  and  index  entries  be  created  in  the  Poisons Standard  for  phenibut  as  follows: Schedule  9 –  New  Entry PHENIBUT. Index  –  New  Entry PHENIBUT cross  reference:  BETA-PHENYL-GAMMA-AMINOBUTYRIC ACID Schedule  9 The  committee  also  recommended  an  implementation  date  of  1 February  2018. Members  agreed  that  the  relevant  matters  under  Section  52E(1)  of  the  Therapeutic  Goods  Act  1989 included: 

(a)  risks  and  benefits  of  the  use  of  a  substance; 
(b)  the  purpose  for  which  a  substance  is to  be used  and  the  and  extent  of  use;
(c)  the  toxicity  of  a  substance; 
(d)  the  dosage, formulation, labelling, packaging  and  presentation  of  a  substance; 
(e)  the  potential  for  abuse  of  a  substance;  and 
(f)  any  other matters  that  the  Secretary  considers  necessary  to protect  public  health.

The  reasons  for  the  advice  were:

•  Risks of  phenibut  include  tolerance, dependence, abuse, accidental  and  intentional  overdose resulting  in  significant  toxicity  requiring  hospitalisation,  with  severity  potentially  requiring  ICU admission.

•  There are anecdotal  reports  of  the  therapeutic  benefit  of  phenibut  based  on  public  submissions. •  Although phenibut  is  used  therapeutically  in  Russia, the  associated  clinical  trial  literature  is  unable to be  evaluated  critically  at  this  time  due  to translation  issues. Furthermore, there  has  been  no established  therapeutic  benefit  of  phenibut  in  regulatory  comparable  countries.

•  Taking into consideration  the  danger  to the  health of  individuals  and  of  the  community  (both immediate  and  imminent)  associated  with the  use  of  phenibut  and  the  high risk  of  dependency, abuse,  misuse  and  illicit,  the  perceived  benefits (as indicated  in  public  submissions)  are substantially  outweighed  by  the  risks.   

•  The substance  is  not  currently  permitted  in  Australia  to be  marketed  for  therapeutic  reasons  but  is widely  available  on  the  internet  for  purchase. International  websites  make  significant  therapeutic claims  for  cognition  enhancement, anxiety  and  depressive  disorders. Prevalence  of  use  is  not established  but  is clearly  across the  country  and  increasing.

•  Phenibut  is  a  neuropsychotropic  drug  with anxiolytic  and  cognition  enhancing  effects. It  acts  as  a GABA mimetic, primarily  at  GABAB  and  to some  extent  at  GABAA  receptors. Published  reports  of ED presentations, acute  intoxication  with delirium, and  dependence  treated  with baclofen. These reports  include  reports  from  Australia. Descriptions  of  withdrawal  include  tremors, anxiety, insomnia,  hypertension,  hyperhidrosis,  psychosis,  tachycardia,  widening  of  QRS  complex  and convulsions. There  is  significant  risk  of  harm. Effects  include  CNS  depression, delirium, seizures  – potentially  requiring  intubation  and  ventilation. 

•  Rapid development  of  tolerance  and  dependence  with a  withdrawal  syndrome  consisting  of hallucinations, agitation, tremor, insomnia, abdominal  pain, vomiting.

•  The availability  as a  powder  increases risks of  toxicity.

Delegate’s  considerations The  delegate  considered  the  following  regarding  this  proposal:

•  Scheduling  proposal
•  ACCS-ACMS advice •  Public Submissions received
•  Section  52E  of  the  Therapeutic  Goods  Act  1989
•  Scheduling  Policy  Framework  (SPF  2015)
•  Other relevant  information Delegate’s  interim  decision The  delegate’s interim  decision  is  to create  new  Schedule  9  and  index  entry  in  the  Poisons  Standard  for phenibut.

The  proposed  Schedule  entry  is  as  follows: Schedule  9  –  New  Entry PHENIBUT. Index  – 
New  Entry PHENIBUT cross  reference:  BETA-PHENYL-GAMMA-AMINOBUTYRIC ACID Schedule  9.


The  proposed  implementation  date  is  1 February  2018 as this is the  earliest  possible  implementation date.[/color]
 
The  matters  under  subsection  52E(1)  of  the  Therapeutic  Goods  Act  1989  considered  relevant  by  the delegate  included:

(a)  the  risks  and  benefits  of  the  use  of  a  substance;
(b)  the  purposes  for  which a substance  is  to be  used  and  the  extent  of  use  of  a  substance; 
(c)  the  toxicity  of  a  substance; 
(d)  the dosage, formulation, labelling, packaging  and  presentation  of  a  substance; 
(e)  the  potential  for  abuse  of a  substance;  and 
(f)  any  other  matters  that  the  Secretary  considers  necessary  to protect  public  health.

The  reasons  for  the  interim  decision  are:

(a)  the  risks  and  benefits  of  the  use  of  a  substance:
 
•  There are anecdotal  reports  of  the  therapeutic  benefit  of  phenibut  based  on  public  submissions. 
•  Although phenibut  is  used  therapeutically  in  Russia, the  associated  clinical  trial  literature  is  unable to be  evaluated  critically  at  this  time  due  to translation  issues. Furthermore, there  has  been  no established  therapeutic  benefit  of  phenibut  in  regulatory  comparable  countries.
•  International  websites  make  significant  therapeutic  claims  for  cognition  enhancement, anxiety  and depressive  disorders.
•  Risks  of phenibut  include  tolerance, dependence, abuse, accidental  and  intentional  overdose resulting  in  significant  toxicity  requiring  hospitalisation,  with  severity  potentially  requiring  ICU admission.
•  The perceived  benefits (as indicated  in  public  submissions)  are  substantially  outweighed  by  the risks.

(b)  the  purposes  for  which a  substance  is  to be  used  and  the  extent  of  use  of  a  subalance.

The substance  is  not  currently  permitted  in  Australia  to be  marketed  for  therapeutic  reasons  but  is widely  available  on  the  internet  for  purchase. International  websites  make  significant  therapeutic claims  for  cognition  enhancement, anxiety  and  depressive  disorders. Prevalence  of  use  is  not established  but  is clearly  across the  country  and  increasing.

•  Prevalence of  use  is  not  established  but  is  clearly  across  the  country  and  increasing.

(c)  the  toxicity  of  a  substance:

•  Phenibut  is  a  neuropsychotropic  drug  with anxiolytic  and  cognition  enhancing  effects. It  acts  as  a GABA mimetic, primarily  at  GABAB  and  to some  extent  at  GABAA  receptors. 
•  Published  reports  of  ED  presentations, acute  intoxication  with delirium, and  dependence  treated with baclofen. These  reports  include  reports  from  Australia.   
•  Descriptions  of  withdrawal  include  tremors, anxiety, insomnia, hypertension, hyperhidrosis, psychosis,  tachycardia,  widening  of  QRS  complex  and  convulsions.  There  is significant  risk  of  harm.   
•  Effects  include  CNS  depression, delirium, seizures  –  potentially  requiring  intubation  and ventilation. 
•  The availability  as a  powder  increases risks of  toxicity.

(d)  the  dosage, formulation,  labelling, packaging  and  presentation  of  a  substance:

•  Packaged  as  a supplement  in  250  and  500mg  capsules.
•  No restrictions  at  present, currently  available  in  powder  and  capsules  with variable  labelling. 
•  The availability  as  a  powder  increases  risks  of  toxicity. Loose  powders  pose  particular  risk  of accidental  overdose.   

(e)  the  potential  for  abuse  of  a  substance:

•  Rapid development  of  tolerance  and  dependence  with a  withdrawal  syndrome  consisting  of hallucinations, agitation, tremor, insomnia, abdominal  pain, vomiting.
•  Cases of  recreational  abuse  have  been  described.   
•  Rapid development  of  tolerance  is  established.

(f)  any  other  matters  that  the  Secretary  considers  necessary  to protect  public  health:

•  Taking into consideration  the  danger  to the  health of  individuals  and  of  the  community  (both immediate  and  imminent)  associated  with the  use  of  phenibut  and  the  high risk  of  dependency, abuse,  misuse  and  illicit,  the  perceived  benefits (as indicated  in  public  submissions)  are substantially  outweighed  by  the  risks.
« Last Edit: September 24, 2017, 01:16:57 PM by chipper »
Over 90% of all computer problems can be traced back to the interface between the keyboard and the chair !

Offline limerence

  • Jr. Member
  • **
  • Join Date: Oct 2015
  • Location:
  • Posts: 72
  • Reputation Power: 2
  • limerence is new on the scene.
  • Gender: Male
  • Last Login:July 02, 2018, 06:26:18 PM
  • Our Community Board
Re: TGA proposes to schedule Phenibut as S9 (banned, no medical use)
« Reply #1 on: March 30, 2018, 11:37:16 AM »
Quote
some  extent  at  GABAA  receptors
Go figure. This probably isnt the best thread to ask, but anyone know more about how Phenibut works?

Tags:
 

Related Topics

  Subject / Started by Replies Last post
9 Replies
3187 Views
Last post June 16, 2017, 06:44:59 PM
by Chip
14 Replies
3573 Views
Last post November 05, 2015, 07:05:42 AM
by _Enduser
23 Replies
7989 Views
Last post August 05, 2016, 11:14:16 PM
by smalls
0 Replies
393 Views
Last post April 14, 2016, 09:38:13 AM
by Z
0 Replies
941 Views
Last post October 11, 2016, 01:45:30 PM
by Chip
16 Replies
4144 Views
Last post December 07, 2016, 07:41:06 AM
by Bodytec
0 Replies
879 Views
Last post March 09, 2017, 03:12:41 PM
by FreddyDaddy1940
5 Replies
2473 Views
Last post September 13, 2017, 08:59:08 AM
by Chip
3 Replies
1015 Views
Last post December 02, 2017, 10:16:46 PM
by dillydudeEL14
0 Replies
16 Views
Last post June 12, 2018, 06:13:44 PM
by joshstock2




TERMS AND CONDITIONS

In no event will d&u or any person involved in creating, producing, or distributing site information be liable for any direct, indirect, incidental, punitive, special or consequential damages arising out of the use of or inability to use d&u. You agree to indemnify and hold harmless d&u, its domain founders, sponsors, maintainers, server administrators, volunteers and contributors from and against all liability, claims, damages, costs and expenses, including legal fees, that arise directly or indirectly from the use of any part of the d&u site.


TO USE THIS WEBSITE YOU MUST AGREE TO THE TERMS AND CONDITIONS ABOVE



Founded December 2014