As opposed to current treatment options, which are mostly phosphate binders requiring multigram quantities, tenapanor is expected to significantly reduce patient pill burden
. The twice-daily dosing also facilitates improved patient adherence and compliance.
Amy Schulman, CEO and co-founder of Lyndra Therapeutics, said, 'Gilead has led the way in HIV prevention and treatment by focusing on reducing pill burden
through the development of single-tablet oral regimens for their therapies, addressing an epidemic that affects nearly 40 million people globally.
In addition, the pill burden
and need for daily administration of currently recommended ART regimens impacts tolerability and may influence adherence.
Consequently, these patients have to take a large pill burden
on an average of around 8-10 tablets/day.
Barriers to medication adherence identified were patient behaviour (intentional and un-intentional non-adherence), comorbidity and pill burden
, cost-related non-adherence, and low patient knowledge.
Pharmaceutical manufacturers can sometimes minimize pill burden
without jeopardizing these factors by using polymers with high glass transition temperatures (Tg) to maintain physical stability, distributing stabilizing polymers across the SDD and drug product to maintain performance and engineering SDD particle size and morphology to facilitate favorable downstream manufacturing.
Reaching 120 mm Hg generally took one extra drug (an average of 2.8), and the overall pill burden
did matter; 2,463 patients in the intensive arm on fewer than five medications dropped their mean SBP 20 mm Hg at 1 year, while 1,698 taking more than five had a 15-mm Hg reduction.
It further documented that marital status, educational level, employment status, co-morbidities such as type 2 diabetes, number of medications and pill burden
were all factors that significantly led to higher perceived treatment burden.
The primary difference is a potentially smaller pill burden
: People using on-demand PrEP take on average about half the number of pills as someone on daily PrEP, which could lower the cost of prophylaxis in countries or settings where the person on PrEP has financial responsibility for the drugs.
The analyst says the company's tenapanor in hyperphosphatemia addresses a major unmet medical need by offering the lowest pill burden
among available phosphate binders on the market.