Botulinum toxin’s off-label uses – Conversation – Express Pharma Pulse

Botulinum toxin’s off-label uses

Poison for Beauty

Botulinum toxin, the first poison approved by US FDA for treatment of certain muscle conditions as well as for its ‘off label’ uses for a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, etc has now returned in a new avatar as a wonder drug for facial beauty

The world’s worst poison is becoming US’ first wonder drug for facial beauty

Everything has its own use, but an old poison has its multiple uses and in two contradictory types of uses, too. Botulinum Toxin is a very potent poison, reportedly, one gm of the toxin dispersed evenly and inhaled can kill millions of people. It is declared as potential bio-weapon and Iraq has confirmed to have made bio-weapons using the botulinum toxin. Iraq chose to weaponize more botulinum toxin than any other of its known biological agents like alfatoxin and anthrax spores. It’s supposedly the most poisonous substance known.

It is also the first poison, which is approved by US FDA for treatment of certain muscle conditions like in cervical torticollis, strabismus, and blepharospasm associated with dystonia. But it is used more for its ‘‘off label’’ uses – a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, traumatic brain injury, cerebral palsy, achalasia, and various dystonias. But, now, the world’s worst poison is becoming US’ first wonder drug for facial beauty.

The US FDA recently approved the use of this toxin, of course in purified form and under professional supervision, for treatment of wrinkles between the brows. Though this use of the drug is famous for some time already, it was one of the “off-label” uses. The new approval came for the Botox Cosmetic (botulinum toxin type A) for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women 65 or younger. The approval specifically applies to the vertical lines between the eyebrows.

Botox, the approved product by Allergan, will be marketed for this use under the name Botox Cosmetic with dosing specific to treat frown lines. The drug – in purified protein form – is a dilute injectable which needs to administered in a few tiny injections at the site of the furrows and very slowly. The discomfort of injection between the brows is seemingly insignificant compared to its effect in the people fighting to keep the age lines away from their beautiful faces. The effect is temporary lasting for about 40 days, and ensures necessity for repeat treatment in the captive patient groups. Thus the product is expected to be a fast moving drug and the benefit is for the doctors and the manufacturers as well.

The clinical study for the indication involved 537 patients, undergoing a repeated treatment by either Botox (405 patients) or placebo (132 patients). It was conducted in two parts first being the double blind, placebo controlled study for evaluating the efficacy. The second part was eight month, open label study for safety with 373 patients continuing from the first part.

In the first part maximum response was noted after 30 days, the reduction in the severity of glabellar lines at maximum frown was the measure of the effect. The investigator found 80.2 per cent versus 3.0 per cent benefited by Botox and self-assessed results were 89.4 per cent versus 6.8 per cent in favour of Botox compared to the placebo. The most noted adverse effects were headache (13.3 per cent of those treated with Botox Cosmetic versus 17.7 per cent of those treated with placebo), respiratory infection (3.5 per cent versus 3.8 per cent with placebo), blepharoptosis or temporary eyelid droop (3.2 per cent versus 0 per cent with placebo), nausea (3.0 per cent versus 2.3 per cent with placebo) and flu syndrome (2.0 per cent versus 1.5 per cent with placebo). Less frequently occurring adverse reactions included pain in the face, erythema (redness) at the injection site and muscle weakness. These events occurred within the first week and are thought to be associated with the injection.

Botox is already the most popular cosmetic procedure in US to smooth out the lines on aging faces and the Hollywood directors have reportedly complained about the immobile faces of the performers. Still, it is welcomed by the beauty-conscious and is expected to be more famous now that the cosmetic use is approved. More and more studies are being done on Botox (Botulinum Type A) and Myoblock (Botulinum type B) and indications of their various uses are being reported as in post-whiplash headaches, vocal tremors and Piriformis Syndrome pain, as also its Antihidrotic effect, effect in lazy bladder syndrome etc.

Meena Shah