Dubbed as the “little neurotoxin that could,” by USA Today, Botox now boasts sales of well over $1 billion for its manufacturer, Allergan. Many of us who start to see our migraine-furrowed forehead lines show up in our 30s think: hey, maybe Botox for migraine could help me too. But before you say “heck yes!” at the next Botox party or med-spa, be sure you know what you’re getting into.
Don’t be a pill. You're more likely to get a bruise at the site of the needle injection if you're taking aspirin or ibuprofen; these medications thin the blood and increase bleeding which causes the bruise. Skip the pills for two weeks in advance of your treatment. You should also tell your doctor -- before treatment -- about any supplements you're taking, even if they're "natural," because some (such as fish oil pills, gingko, or vitamin E) also thin blood. Your doctor may ask you not to use those supplements for two weeks before your treatment.
On July 7, 2015, the company acquired the rights to the late stage CGRP migraine portfolio of Merck & Co, as well as two experimental drugs (MK-1602 and MK-8031) for an upfront payment of $250 million. On August 10, the company acquired Oculeve for $125 million. On August 31, the company acquired Naurex for an upfront payment of $560 million. On October 19, the company acquired AqueSys, developer of ocular implants that reduce intraocular pressure associated with glaucoma, for an initial payment of $300 million. On October 1, the company acquired Kythera Biopharmaceuticals, a company focused on the medical aesthetics market, for $2.1 billion. On November 4 the company announced the acquisition of Northwood Medical Innovation, developer of earFold, a medical device to correct protruding ears. On November 25, 2015, the company announced it would partner with Rugen Therapeutic to develop new therapies for autism spectrum disorder, rabies and obsessive compulsive disorder.
The range of prices for a single unit of Botox range between $10 and $20 per unit. But the total cost of Botox treatment depends on exactly what you're trying to achieve. For example, the cost of treating horizontal forehead lines may range anywhere from $300 to $700 depending on the factors mentioned above. For other facial areas you may need fewer units.
The efficacy and safety of BOTOX for the treatment of lower limb spasticity was evaluated in Study 6, a randomized, multi-center, double-blind, placebo-controlled study. Study 6 included 468 post-stroke patients (233 BOTOX and 235 placebo) with ankle spasticity (modified Ashworth Scale ankle score of at least 3) who were at least 3 months post-stroke. A total dose of 300 Units of BOTOX or placebo were injected intramuscularly and divided between the gastrocnemius, soleus, and tibialis posterior, with optional injection into the flexor hallucis longus, flexor digitorum longus, flexor digitorum brevis, extensor hallucis, and rectus femoris (see Table 33) with up to an additional 100 Units (400 Units total dose). The use of electromyographic guidance or nerve stimulation was required to assist in proper muscle localization for injections. Patients were followed for 12 weeks.
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
Dr. Starling says the FDA approval indicates that the anti-CGRP treatments are ideal for individuals with episodic migraine who have four to 14 headache days per month, and people with chronic migraine who have 15 or more headache days per month. Clinical trials are also being conducted to see if anti-CGRP antibodies are effective for the treatment of cluster headache. “The initial studies have demonstrated that it’s likely effective for cluster headache patients,” Dr. Starling says. The FDA’s approval of these medications has been incredibly meaningful for the migraine community. “The migraine community is feeling like they’re relevant—that they’re being seen, heard and taken seriously,” Dr. Starling says. “There are many people who are working hard to develop more treatment options until we can address every patient who has migraine, and eventually find a cure.”
When my babies were little, I never discussed migraine with them. As they grew into preschool and elementary age, I found it necessary to explain it to them. They had seen me experience migraine symptoms for a long time but understood it as just being sick. We went to a migraine walk where we talked about how others cope like I do, and they heard other stories that were similar to mine. They felt empowered that we had fundraised for a disease that affects millions and that we were fighting it as a family and community. My children want to help. Having ways they can help builds their confidence in their ability to take care of me, as I do them. They know to turn the lights off, get ice and talk quietly. I have taught them how to be self-sufficient. I’m so proud of how they take care of themselves and are willing to take care of others. The qualities that they’re learning and displaying will carry them through life.
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.
The Company is developing a number of products, some of which utilize drug delivery systems, through a combination of internal and collaborative programs, such as Esmya, Sarecycline, Ubrogepant, Abicipar, Bimatoprost SR, Relamorelin, Rapastinel, Cenicriviroc and Atogepant. The Company's portfolio of branded pharmaceutical products within the US Specialized Therapeutics, US General Medicine and International segments includes Alphagan/Combigan, which is used for the treatment of selective alpha2 agonist; Armour Thyroid, which is used for the treatment of Underactive thyroid; Asacol/Delzicol, which is used for the treatment of ulcerative colitis; Botox, which is used for the treatment of acetylcholine release inhibitor; Bystolic, which is used for the treatment of hypertension; Carafate/Sulcrate, which is used for the treatment of ulcerative colitis, and Dalvance, which is used for the treatment of acute bacterial skin infections. It also offers Estrace Cream, which is used for the treatment of hormone therapy; Linzess/Constella, which is used for the treatment of irritable bowel syndrome; Lo Loestrin which is an oral contraceptive; Lumigan/Ganfort, which is used for the treatment of prostaglandin analogue; Minastrin 24, which is an oral contraceptive; Namenda IR, Namenda XR and Namzaric, which are used for the treatment of Dementia; Restasis, which is used for the treatment of topical immunomodulator; Saphris, which is used for the treatment of schizophrenia, bipolar mania; Teflaro, which is used for the treatment of acute bacterial skin infections, community-acquired bacterial pneumonia; Viberzi, which is used for the treatment of irritable bowel syndrome; Viibryd/Fetzima, which is used for the treatment of depressive disorders, and Zenpep, which is used for the treatment of exocrine pancreatic insufficiency. The Company also offers CoolSculpting, which is a controlled-cooling fat reducing system.
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically. Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals. Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult. Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.
Charges can vary from $8 to $20 a unit depending on where you are in the country and the level of dilution, meaning that the price may actually be higher than the quoted price if a clinic dilutes it out instead of preparing full-strength Botox. The cost of the procedure varies as it depends upon the total number of units injected and the number of sites treated.
Galli has been living with migraine for most of her adult life, but recently, her attacks became more severe and frequent. “My whole life went upside down and nothing was the same,” Galli says, upon being diagnosed with chronic migraine. “The person I used to be wasn't there anymore. I didn't even recognize myself.” To cope with the symptoms that often accompany chronic migraine, Galli found herself retreating to a dark room, waiting for the pain to pass, but it never did. In response, Galli says, she asked herself what she could do to feel better but also share her story. “Everyone around me that knew how high energy, and how much of a go-getter I am, asked what was happening? Where was that person?” When she came across the announcement of the Migraine Moment Film Contest, she saw it as her opportunity to bring awareness about what it is like to live with migraine and bust the misconceptions surrounding this invisible disease. Enter: “Invisible Hero.”
Some service providers offer financing options to make the procedure affordable. The Botox Cosmetic product is eligible for the Brilliant Distinctions Program that helps the members through savings, rebates, bonus points, and other perks. But there are also some providers with their own rebate program that gives a discount on the next procedure by 10% to 25%. Coupons are available in forms of discount, promo or free service for loyal customers. Also, a large volume of Botox used in the treatment, there is a possibility to avail discounted price of the Botox per unit.
Ratings on RealSelf.com (www.RealSelf.com) show a satisfaction rate of 65% for Botox, which is on par with other treatments such as Restylane, Juvederm, and Perlane and slightly higher than Xeomin and Dysport. Longer-term treatments, such as Ultherapy facial tightening and Liposuction/SmartLipo achieve ratings in the 80% and above area, while others such as CoolSculpting (Zeltiq) achieve ratings in the 70% area. This may reflect upon the short-term nature of all botulinum toxins versus the longer-term nature of these other procedures.
In two double-blind, placebo-controlled trials in patients with detrusor overactivity associated with a neurologic condition (NDO-1 and NDO-2), the proportion of subjects who were not using clean intermittent catheterization (CIC) prior to inject ion and who subsequently required catheterization for urinary retention following treatment with BOTOX 200 Units or placebo is shown in Table 9. The duration of post-injection catheterization for those who developed urinary retention is also shown.
BTX-A has also been used in the treatment of gummy smiles, the material is injected into the hyperactive muscles of upper lip, which causes a reduction in the upward movement of lip thus resulting in a smile with a less exposure of gingiva. Botox is usually injected in the three lip elevator muscles that converge on the lateral side of the ala of the nose; the levator labii superioris (LLS), the levator labii superioris alaeque nasi muscle (LLSAN), and the zygomaticus minor (ZMi).
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.
Over the next three decades, 1895-1925, as food canning was approaching a billion-dollar-a-year industry, botulism was becoming a public health hazard. Karl Friedrich Meyer, a prodigiously productive Swiss-American veterinary scientist created a center at the Hooper Foundation in San Francisco, where he developed techniques for growing the organism and extracting the toxin, and conversely, for preventing organism growth and toxin production, and inactivating the toxin by heating. The California canning industry was thereby preserved.
Therefore, it is important to remember that if a clinic or medical spa states that they are providing Botox at a certain dollar amount per unit, it is quite possible that they are diluting the Botox and actually not providing the agreed-upon amount. This is much like the concept of a watered-down drink at a bar, but the costs are much larger when it comes to Botox or its alternatives, Dysport and Xeomin.
Robert Anolik, a board-certified, cosmetic dermatologist explains, "The cost for these types of treatments is widely variable, as every patient needs different amounts and in different areas. It could be a few hundred dollars to a few thousand. For example, a patient may have deepened nasolabial folds (smile lines) requiring multiple syringes of Restylane Defyne. Or a patient could need a subtle lift with a small amount of Restylane-Lyft in the cheeks and mid-face. I find many of my patients will come in consistently for Dysport (Dysport spreads out a bit more, so you're able to get a better global balancing, whereas Botox has a little more of an isolated effect) every three to four months on average, and then we will review what might be needed among the fillers. Often more syringes of filler may be needed at first and then we can maintain over time."
Some doctors, however, say their experience with their own patients indicates Botox — which was approved by the FDA in 2010 to treat migraines — is quite effective for this purpose. Lawrence Newman, MD, a neurologist and director of the headache division at NYU Langone Medical Center in New York City, says many of his patients have experienced a significant decline in the number of headaches per month after receiving Botox. In many cases, he says, it has cut down that number by 50% and frequently more than that.
The recommended dilution is 200 Units/4 mL or 100 Units/2 mL with preservative -free 0.9% Sodium Chloride Injection, USP (see Table 1). The lowest recommended starting dose should be used, and no more than 50 Units p er site should generally be administered. An appropriately sized needle (e.g., 25-30 gauge) may be used for superficial muscles, and a longer 22 gauge needle may be used for deeper musculature. Localization of the involved muscles with techniques such as needle electromyographic guidance or nerve stimulation is recommended.