Calcitonin gene-related peptide (CGRP) is a neuropeptide found all over the body, says Dr. Amaal Starling, an Assistant Professor of Neurology at the Mayo Clinic in Phoenix. This neuropeptide attaches to a receptor called a CGRP receptor. CGRP and its receptor are involved in numerous bodily processes—from gastrointestinal movement to the transmission of pain. Over the past few decades, there has been increasing evidence that CGRP plays a role in both migraine and cluster headache. During a migraine attack, researchers have found increased levels of CGRP in patients’ blood and saliva. They discovered migraine medications like sumatriptan reduced levels of CGRP in patients living with migraine. They also found that patients with chronic migraine—meaning 15 or more migraine days per month, eight of which either meet criteria for migraine or are treated with migraine-specific medication—had chronically elevated levels of CGRP. In addition, recent research found that giving a patient with migraine an infusion of CGRP would lead to a migraine-like attack. “All of these studies led to the hypothesis that CGRP and its receptor play a key role in migraine, as well as in cluster headache,” Dr. Starling says.
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
A follow-up visit is most often scheduled at around three months after injection. The team will determine if it was helpful and if the effect is wearing off. The effect on muscle spasticity by botulinum toxin is temporary and can last for up to three to five months. This also varies with the amount of toxin injected, the size of the muscle, the degree of spasticity in the muscle, and treatment such as therapy and bracing.
Now Allergan hopes to replicate the findings on a larger scale, and the company is currently running its own Phase 2 clinical trial. If its results are in line with Rosenthal and Finzi's, it would be huge, paving the way for Botox to obtain official approval for the drug as a depression treatment. That wouldn't change anything for doctors, of course--they can already prescribe it off-label, and some do, with great results--but it would allow Allergan to begin marketing Botox for depression, a change that could dramatically increase its adoption and sales.
On July 29, 2016, Food and Drug Administration (FDA), of the United States of America approved abobotulinumtoxinA for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older.[20] AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. In the United States of America, the FDA approves the text of the labels of prescription medicines. The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to prescribe these drugs may freely prescribe them for any condition they wish, called off-label use. Botulinum toxins have been used off-label for several pediatric conditions, including infantile esotropia.[21]
Preventative Botox has been getting lots of buzz. “It can potentially have a preventive effect on dynamic wrinkles, which are caused by underlying muscle movement,” Shah explains. “That being said, muscle movement is only one factor that contributes to the development of wrinkles, so Botox may not be completely preventive.” (Some other wrinkle causes: sun exposure, smoking, and diet.)
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
Two preparations of botulinum antitoxins are available for treatment of botulism. Trivalent (A,B,E) botulinum antitoxin is derived from equine sources using whole antibodies. The second antitoxin is Heptavalent (A,B,C,D,E,F,G) botulinum antitoxin, which is derived from equine antibodies which have been altered to make them less immunogenic. This antitoxin is effective against all known strains of botulism.
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.
BTX-A has also been used in the treatment of gummy smiles,[80][81] 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.[82] 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).[83][84]
Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction were also observed. These primary and secondary endpoints are shown in Table 23.
Preventative Botox has been getting lots of buzz. “It can potentially have a preventive effect on dynamic wrinkles, which are caused by underlying muscle movement,” Shah explains. “That being said, muscle movement is only one factor that contributes to the development of wrinkles, so Botox may not be completely preventive.” (Some other wrinkle causes: sun exposure, smoking, and diet.)
Botox lasts only around three months (or more when you first start getting injections), so get ready to go in for maintenance every three to six months. Because it’s only meant to temporarily relax your muscles, it wears off over time, and you’ll notice your wrinkle start to appear again. “As skin ages, the skin loses elasticity and collagen breaks down, so constant muscle and skin contraction can create more permanent creases (wrinkles). Within a few months of injecting the botox, the body makes new acetylcholine receptors, and the nerves are able to conduct their impulses again,” Dr. Shainhouse explains. “You must use neurotoxins continuously in order to reduce muscle movement and prevent long-term skin creasing.” Find out more secrets from dermatologists about how to prevent and treat wrinkles.

One of the most beneficial uses of BOTOX\for migraines is that it can serve as an indicator of how effective migraine surgery might be for you. BOTOX stops contracting muscles from irritating triggering nerves. If that gives you relief, you may benefit from surgery to “free up” pressure on those nerves. Using BOTOX may also help identify which nerves could be triggering your migraines, making surgical intervention more targeted.
Good question. botox can be used to help elevate the eyebrows, which contribute to the heavy lid look. You want the "depressor muscles" of the brow weakened leaving the "elevator muscles" still functional. It will give some lift. It may not be enough depending on the severity of the heaviness to your eyelids. A board certified plastic surgeons should be able to advise you... READ MORE

Jump up ^ Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K (February 2001). "Botulinum toxin as a biological weapon: medical and public health management". JAMA. 285 (8): 1059–70. doi:10.1001/jama.285.8.1059. PMID 11209178.


SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum/PA++++ Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum/PA++++ Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products that are formulated and marketed pursuant to the FDA's governing regulations set forth at 21 CFR § 352.
The recommended dilution is 200 Units/2 mL, 200 Units/4 mL, 100 Units/1 mL, or 100 Units/2 mL with preservative-free 0.9% Sodium Chloride Injection, USP, depending on volume and number of injection sites desired to achieve treatment objectives (see Table 1). In general, no more than 50 Units per site should be administered using a sterile needle (e.g., 25-30 gauge) of an appropriate length. Localization of the involved muscles with electromyographic guidance may be useful.
But in a recent Fat Mascara podcast, NYC dermatologist Pat Wexler, MD, said this is a myth. And Dr. Matarasso falls somewhere in-between. “For aesthetic or cosmetic reasons, does a 19-year-old need this? No. Does a 26-year-old need this for aesthetic purposes? Highly doubtful. But, hey, listen, if you are like, ‘I am looking at my parents, I am looking at my genes, and I want to stay proactive,’ it is not unreasonable to introduce it in small amounts.”
Pharmaceutical companies are not without blame. One reason why insurers impose step therapy is high drug prices. Botox, which is made from the toxin of certain bacteria, is much more expensive than other migraine treatments like beta blockers, which are available as generics. Botox costs about $4,800 a year, but with injection fees, treatment can cost up to $10,000 a year. “They could lower the price,” says Loder. “Their goal is to maximize return on investment for their stockholders. That’s not the same thing as maximizing benefits for patients, unfortunately.”

The drug has come a long way since its ability to smooth facial wrinkles was first discovered, by accident. In the 1970s, ophthalmologist Dr. Alan B. Scott started studying the toxin as a therapy for people with a medical condition that rendered them cross-eyed. "Some of these patients that would come would kind of joke and say, 'Oh, Doctor, I've come to get the lines out.' And I would laugh, but I really wasn't tuned in to the practical, and valuable, aspect of that," Scott told CBS in 2012. Scott named the drug Oculinum and formed a company of the same name in 1978. In 1989 he received FDA approval for the treatment of strabismus (the crossed-eye disorder) and abnormal eyelid spasms.
In a study to evaluate inadvertent peribladder administration, bladder stones were observed in 1 of 4 mal e monkeys that were injected with a total of 6.8 Units/kg divided into the prostatic urethra and proximal rectum (single administration). No bladder stones were observed in male or female monkeys following injection of up to 36 Units/kg (~12X the highest human bladder dose) directly to the bladder as either single or 4 repeat dose injections or in female rats for single injections up to 100 Units/kg (~33X the highest human bladder dose).
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e. g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from therapeutic doses of BOTOX [see Dysphagia And Breathing Difficulties].
Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”

Not to be evasive, but the cost varies between physicians depending on how much Allergan product they purchase in a year. In general, it will probably be from $500 to $550 for a 100 unit vial. The equipment required to properly inject botox is not cheap, since it takes specialized syringes and needles that aid in precision and comfort. And properly trained staff and appropriately-medical... READ MORE

With depression, Rosenthal and Finzi think it may relate to what's known as the facial-feedback hypothesis, a theory stemming from research by Charles Darwin and further explored by the American philosopher and psychologist William James. The theory posits that people's facial expressions can influence their mood. Lift your face into a smile and it may just cheer you up; if you can't frown or furrow your brow in worry, perhaps you won't feel so anxious or sad.
Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.
These injection sites have been carefully chosen to treat specific nerve endings that are sending pain signals. BOTOX for migraines has proven to be a highly-effective treatment for people who are living with the painful, debilitating symptoms of chronic migraines. BOTOX will be carefully and correctly injected into muscles just beneath the skin. The procedure is not particularly painful, with a sensation of pinpricks.

Allergan’s Phase 3 hypothesis for securing conditional accelerated approval is to demonstrate that CVC treatment therapeutically initiates and induces improvement in histological hepatic fibrosis without worsening of NASH resolution. Notably, establishing improvement in NASH resolution after CVC therapy in NASH is not a prerequisite for attaining FDA conditional accelerated approval. A Phase 3 interim data readout for FDA Subpart H conditional accelerated approval is anticipated possibly in H1/2019.

When the deal with Teva closed in August 2016, it left Allergan with $40 billion to spend. Some of that went to repurchase shares, while some went to a series of acquisitions that totaled about $6.5 billion. One of the bigger deals was for a company developing treatments for NASH, a liver condition that Saunders said would become "one of the next epidemic-level chronic diseases we face as a society."
Other than that, there don’t seem to be any specific groups of people or health conditions that are contraindicated for Botox injections. As with all treatments, general health guidelines apply. People with a healthy body-mass index who are non-smokers, moderate or non-drinkers, and physically active will nearly always tolerate any type of medical treatment well.
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist f or several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Allergan has a deep commitment to the health and well-being of patients who use our products and the global communities where we operate. We are focused on access to our medicines, as well as environmental, health and sustainability initiatives. In 2016, Allergan introduced Our Social Contract with Patients, focused on four areas – Invest & Innovate, Access & Pricing, Quality & Safety, and Education -- where Allergan is committed to doing what is right for patients and society

The cost for Botox may range from $125 to $400 per treatment area. Multiple areas may be treated at one time, and repeat treatments are needed every three to four months, on average. When it comes to Botox and other injectables, you get what you pay for. Buyer beware: bargain Botox may increase your risk of complications, including poor cosmetic results. If the cost is prohibitive, ask your doctor about payment plans.


Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
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