About a month ago, a number of distributors and online retailers of Adrafinil abruptly stopped stocking and selling Adrafinil. There was little information to be had other than the fact that all online retailers stocking Adrafinil were now stocking “SOLD OUT” signs.
I looked into this and contacted a number of retailers. I asked specifically what information they had about the discontinuation. Nubrain responded with a simple email reply of “no more info”. Butch at AwakeBrain wrote back with more information
“Very little info anywhere. Cephalon was bought out and as part of their consolidation stopped production of Olmifon with very little notice. I only found out when I placed my monthly order from my French supplier. Not that it was being discontinued, but that [it] was discontinued. Sorry, that’s all I know.”
The information that Teva Pharmaceuticals acquired Cephalon led me to inquire at both Teva and Cephalon. Unfortunately, nobody at the US branches of either Teva or Cephalon seemed to know what Olmifon was, other than that it was not a drug that they were currently or had ever marketed in the United States.
Breaking out our basic French skills, we found this document posted by France’s FDA equivalent, AFSSAPS. An english translation of the relevant portion of the document reads as follows:
Reassessment of Adrafinil’s benefits and risks
Olmifon ® tablets, 300 mg (adrafinil) by Cephalon laboratories is a drug that has been approved since July 10, 1981. It has been marketed in France since September 19, 1985.
The drug, classified as a non-amphetamine stimulant, is indicated for the treatment of disorders of vigilance, attention, and ideo-motor slowing in the elderly.
In April 2011, Afssaps [Agence française de sécurité sanitaire des produits de santé] informed the MAH [Marketing Authorization Holder] that they were reassessing the benefits / risks of adrafinil and asked Cephalon to provide all data available regarding the security and efficiency of Olmifon.
Examination of the results of clinical studies made by the laboratory can not conclude on the benefit of adrafinil in disorders of arousal and alertness in the elderly.
Furthermore, given the known adverse effects of this drug, the Board of AMM [Cephalon's Board of Advisors] considers that the benefit / risk ratio of adrafinil is unfavorable and therefore proposes a withdrawal of market authorization.
Cephalon laboratories has informed Afssaps of its decision to stop marketing the drug, which is no longer available in hospital pharmacies as of late September 2011.
In short, the French Government decided to reassess the benefits/risks of Adrafinil and informed Cephalon of their intent. Reviewing clinical studies, the board of AMM decided that they could not conclude that the benefits of Adrafinil outweigh the known adverse effects. The AFSSAPS informed Cephalon of their findings and that they were withdrawing marketing permission of Adrafinil. Cephalon announced their intent to stop marketing the drug, and has discontinued production and marketing of Olmifon in September 2011.
So that’s it, bad news for any of you interested in purchasing Cephalon-brand Adrafinil. Adrafinil is still available through Chinese and Indian manufacturers, but depending on the supplier, purity may be a game of chance.