Days after US regulators accepted a marketing application for its new cholesterol drug Cordaptive, Merck & Co has presented positive data on the compound which reveals its effectiveness in reducing facial flushing.
Results of a six-month study involving 1,613 patients were presented at the European Society of Cardiology meeting in Vienna, Austria, showed that Cordaptive (extended-release niacin/laropiprant) formerly known as MK-0524A, lowered ‘bad’ low-density lipoprotein cholesterol and triglyceride levels, and also increased cardioprotective ‘good’ high-density lipoprotein cholesterol levels, compared to placebo. Patients on Cordaptive reduced their LDL-c levels by 19% and raised HDL-c also by 19%, while 22% enjoyed reduced triglyceride levels.
However the main selling point for Cordaptive, if approved by the US Food and Drug Administration (possibly in the second quarter next year), will be the claim that it can reduce the side effects of facial flushing associated with current niacin treatment, ie Abbott Laboratories’ Niaspan. The study revealed that 69% of patients treated with one gram of Cordaptive reported either no or just mild flushing symptoms during the first week of treatment, compared to 44% of those who received Merck-developed extended-release niacin alone.
Also, 49% of the patients in the extended-release niacin group reported moderate or greater flushing symptoms during week one, compared to 27% on the combination. By week 24, the frequency of moderate or greater flushing was 0.7 days/week among those treated with two grams of extended-release niacin, versus 0.2 days/week for those on two grams of Cordaptive or a placebo. Importantly, more than twice as many patients on extended-release niacin discontinued treatment because of flushing than patients taking the new drug (22% versus 10%).
Two-gram doses of niacin are typically used to boost HDL-c levels but the flushing factor means that the most common prescribed dose is only half a gram and its use has been limited. Abbott has argued that facial flushing is usually a temporary side effect which in most cases can be managed with aspirin, but other observers believe that a more tolerated version of niacin could become a major seller.
However there was a word of warning from Steven Nissen, chair of cardiology at the Cleveland Clinic in Ohio, who noted that in the study Cordaptive did not totally eliminate flushing and there was limited safety evidence about the possible long-term side effects from laropiprant, which is a selective prostaglandin D receptor antagonist.
Isentress review expected to be positive
Meantime, Merck is also hoping for some more good news later this week as an FDA advisory committee will be reviewing the New Jersey-based firm’s investigational HIV treatment Isentress (raltegravir).
The firm’s enthusiasm is due to the fact that staff have posted documents on the agency’s website saying that Phase II and III trial data provide evidence that the antiviral activity of Isentress “is superior to optimised background therapy in treatment-experience patients with few or no remaining treatment options.” There were a higher number of cancers seen in patients receiving the drug, but the FDA staff notes suggest that the imbalance may reflect the low rate of cancers in those on placebo.
If approved, the product would be the first in a new class of antiretrovirals called integrase inhibitors to hit the market and analysts are predicting peak sales of over $1 billion.