BDSI said the modification is necessary to address observations made by the US Food and Drug Administration (FDA) during an inspection of a facility operated by its contract manufacturing organisation (CMO) Aveva.
The agency’s specific concerns focus on the formation of microscopic crystals and a ‘slight fading’ of the colour of the delivery strip observed during 24-month shelf life analysis which it said “may potentially confuse patients.”
In its statement BDSI stressed that the fading and crystal formation do not affect Onsolis’ safety or integrity and attributed the changes to the specific excipient used in production of the drug in the US.
The firm also emphasised that the excipient in question is specific to the manufacture of “Onsolis in the US and is not used in the manufacturing process for BDSI's other products” and added that the delay is not expected to impact the European launch of the drug – under the brand name Breakyl – scheduled later this year.
Relaunch?
BDSI’s use of the term ‘relaunch’ is somewhat confusing given that – according to company spokesman Al Medwar - “The product was not technically off the market.”
The issue – Medwar told in-Pharmatechnologist.com – is that unlike products made by competitors - such as Actiq and Fentora which are made by recent Teva acquisition Cephalon - the FDA's approval of Onsolis’ in 2009 included a risk evaluation mitigation strategy (REMS) requirement.
“The previous REMS left us and our commercial partner in a situation where the selling environment was difficult to impossible.
“As a result, efforts were scaled back considerably pending approval of a classwide REMS. The plan was to re-initiate efforts - ie relaunch - at the time of the classwide REMS where there was a more level playing field.”
The classwide REMS was approved by the FDA on December 28 last year and will come into effect later this month.