Repurposing and re-registering old generics

Generics/Research | Posted 29/09/2017 post-comment0 Post your comment

Finding new indications for existing drugs is better known as drug rediscovery, drug repurposing or drug repositioning. It is cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies, makes it a challenging pursuit [1].

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There are already several successfully rediscovered drugs being used in daily practice. One example is the case of Sildenafil, which was initially intended for the treatment of angina pectoris but, after the observation of persistent erections as an unexpected adverse event, it was repurposed as a therapy for erectile dysfunction (Viagra).

Another example is minoxidil, which was developed to treat ulcers, but proved to be a vasodilator in early trials, and was repurposed for severe hypertension. Then, during the efficacy trials of minoxidil it showed unexpected hair growth as a side effect and was repositioned for the treatment of alopecia.

Drugs that are already approved can also be repositioned for new indications. For example, thalidomide was approved for morning sickness in pregnant women in the 1950s and was subsequently repositioned for the treatment of multiple myeloma in 2006.

Finding alternative treatment options by repurposing generics could bypass much of the costs and time needed to develop new drugs. However, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies present a hurdle to the re-registration of more generics for new indications.

In the following series of two articles the repurposing of thioguanine and challenges in the rediscovery of old generics discussed. 

Related articles
Challenges in the rediscovery of old generics

Repurposing thioguanine

1. Simsek M, Meijer B, van Bodegraven AA, de Boer NKH, Mulder CJJ. Finding hidden treasures in old drugs: the challenges and importance of licensing generics. Drug Discov Today. 2017 Sep 1. doi:10.1016/j.drudis.2017.08.008. [Epub ahead of print]

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