DosePro first launched commercially in the US within the drug/device combination product Sumavel® DosePro®, injectable sumatriptan for migraine headache, approved in 2009 and launched in the US in 2010 and Europe in 2011. Since then, thousands of patients have adopted subcutaneously administered sumatriptan into their armamentarium of migraine treatments. As with small molecule formulations, DosePro can be enabling for difficult formulations and can provide sustainable differentiation in competitive markets where choice of delivery system is critical to patient adoption, adherence, and retention.
1. Biologics and small molecule pharmaceuticals
The pharmacokinetic bioequivalence of subcutaneous delivery by DosePro compared to needle-syringe has been demonstrated clinically with a number of large molecule formulations including HGH, EPO, and monoclonal antibodies, as well as with small molecule pharmaceuticals such as sumatriptan. Molecular integrity after delivery by DosePro has been demonstrated in a number of in vitro studies, including adalimumab (Humira® by AbbVie). For self-administration of important disease-modifying therapies, DosePro may offer just what is needed to introduce patients to injectable therapies and to keep them adherent.
2. High viscosity & high concentration formulations
In a demonstration study, DosePro was shown to deliver formulations up to 400mg/ml in excess of 500cP without degrading delivery time, accuracy, or integrity. For drug products being reformulated from intravenous to subcutaneous administration, DosePro may be truly enabling.
DosePro has been tested with vaccines, and because of its patient-friendly design, may offer a unique solution for adoption of therapeutic vaccines under development, as well as prophylactic vaccines.
Battelle, the world's largest independent research and development organization, has partnered with us in a co-marketing agreement to offer the DosePro technology to pharmaceutical partners for developing innovative injectable products. Battelle's integrated science and technology services include industry-leading formulation capabilities and leading-edge medical device development expertise which can apply DosePro to deliver viscous formulations and customize the user interface. To learn more, click here.