Hair today, still there tomorrow.
A very widespread problem, hair loss affects around 50 million men and 30 million women. Although there is no special potion to reverse genetic or age-related decline, certain products can slow shedding and promote regrowth.
Now, an experimental treatment that’s a new version of a classic drug is about to become readily available, marking the first new hair loss pill in nearly 30 years.
An extended-release oral version of minoxidil – the active ingredient in Rogaine – successfully regrowed hair in men with hair loss over six months in a phase 3 trial.
According to the drug’s developer, Connecticut-based biopharmaceutical company Veradermics, the study included 536 men with mild to moderate hair loss.
Patients received either a daily dose of 8.5 milligrams of the experimental pill, known as VDPHL01, a twice-daily dose, or a placebo.
Both the once-daily and twice-daily doses outperformed the placebo, with users taking the once-daily dose gaining an average of 28.6 hairs per square centimeter of scalp afterward, and 36.4 for those taking it twice daily, compared to 6.6 for patients taking the placebo.
“I’m not surprised by the results, and I think it’s exciting to see positive phase 3 data for an oral treatment for hair loss,” dermatologist Pooja Shah, who was not associated with the study, told Medscape Medical News.
Although oral minoxidil has previously been used to combat hair loss, the treatments were often immediate-release, meaning they were absorbed more quickly by the body and caused more side effects for some users.
A minoxidil pill also carries a serious heart risk, including rapid heart rate, fluid around the heart, and chest pain.
An extended-release version of minoxidil could lower the peak concentration and potentially reduce some side effects, such as dizziness or changes in blood pressure.
The drug was generally well tolerated, with no serious adverse events or treatment-related cardiac adverse events.
However, those who took VDPHL01 reported more frequent swelling and unwanted hair growth than those who received a placebo.
VDPHL01 contains almost twice as much minoxidil as the maximum recommended daily dose of 5 milligrams.
Minoxidil widens blood vessels to increase the flow of nutrients, oxygen and blood to budding hair follicles, thereby prolonging their active growth phase while stimulating dormant follicles to become active.
These results were similar to those of the company’s Phase 2 study of more than 500 men, published last April.
The company has not directly compared its minoxidil pill to conventional oral minoxidil, meaning it is unclear whether their treatment offers more benefits than a cheaper generic drug.
While Veradermics is also recruiting women for its Phase 3 trial for female hair loss, they hope the pill will soon be the first non-hormonal, FDA-approved oral treatment for female hair loss.
“Under our current plan, if our studies continue to show positive results within the time frame that we anticipate, and we submit and receive FDA approval, we believe it could be within two to three years,” Dr. Reid Waldman, a Connecticut dermatologist and CEO of Veradermics, previously told the Post.
Gn bussni
