New drug dosage formula for the treatment of hypertension and heart failure in children

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With today’s major research and development activities of pharmaceutical companies focusedon meeting the needs of an increasingly aging population, children who represent the bulk ofthe dependent population worldwide still remain a widely neglected niche market Therecognition of the rights of children to have access to safe and effective drugs and the needs ofhealthcare providers to receive age-appropriate drug information continues to have a majoreffect on all areas of pediatric pharmaceuticals. In line with this challenge, Proveca’sobjective is to develop a new dosage formula of an off-patent drug for the treatment ofhypertension and heart failure in children and apply for the relevant authorisation. Thecurrently licensed medicine is mainly available in tablet form; however children are eitherunable or unwilling to swallow tablets, proving problematic in the long-term use. Alternativesof the drugs are available in liquid form, however the lack of formalised licensing with anofficial regulatory body causes several concerns. With the formulation of medicines being asignificant parameter to ensure optimal dosing levels with minimal toxicity, the high variationin the currently unlicensed liquid formulations dispensed to children in the UK raisesignificant issues related to patient safety and drug efficacy. With a growing pressure on drugsafety and new requirements on risk evaluation and mitigation strategies (REMS), there is anincreasing need to deliver accuracy and congruence of medication supply to patients.Proveca’s new formulation has the potential to improve children’s physiologic status, qualityof life and length of life. The aim of this Proof of Market is to enable Proveca to investigatethe market requirements and potential for the new drug formulation through the delivery of anin-depth market research.