Regulatory Affairs, Pharmacovigilance

1.) Can the design of the XStraw® be changed?

 

The current design is the only available design so far;
 
This current design has been extensively tested and optimized and is to be seen as safe;
 
Of course, a change in design is technically possible;
 
Crucial functional part is the controller and its movement in the straw;
Therefore we assume that a change of diameter of the straw leads to new handling studies
(human-factor-studies);
 
If a potential client is willing to cover the costs related to such studies we would be happy to support them;
 
A shorter straw, however, is no problem since the controller and the cap remain the same, then;
 
Please feel free to ask for advice…

 


 

2.) Is the XStraw® a medical device?

 

 

 

Yes and No! In Europe, the EMA sees the XStraw® as a primary packaging. In the USA, the FDA sees the XStraw as a drug/device combination  - but with low-key requirements in regard to “leachables / extractables” and “human-factor-studies”…DST is about to establish all documentation to enable a pharma company to use the XStraw® also in the USA. This will comprise essential documents such as a divice history file.

 


 

3.) Experiences with FDA / EMA / else?

 

The former owner had no footprint in the USA by then and did not plan to enter this market; in the meantime we had some inquiries from US-companies and they ask the same question; since two of our existing customers plan to get FDA audits in their manufacturing sites this may happen in near future…; details cannot be disclosed by now;
 
There have been contacts with the ANVISA and all the local authorities such as MHRA UK for example;
Attending various pharma conferences such as EuPFI (European Pediatric Formulation Initiative) and AAPS we know about the different approaches of EMA and FDA to packaging drugs or drug device combinations (combination products); 
 
The former owner did a clinical study phase III as well as a marketing (= human factor evaluation) study; we do own this data as well;
 
Of course we are prepared to match all requirements either from FDA or from EMA jointly with pharma companies interested in our XStraw®;

 


 

4.) Any complaints from market?

 

The former owner had a pharmacovigilance system in place during the active period; no report of any issue was ever made according to our records; the drug delivery device itself can be seen as absolutely safe;
Since the products were launched in many countries, the data base is rather broad and therefore meaningful;
 
An extensive marketing study clearly showed that malfunction and misuse can be ruled out;