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.[12] On August 10, the company acquired Oculeve for $125 million.[13] On August 31, the company acquired Naurex for an upfront payment of $560 million.[14] 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.[15] On October 1, the company acquired Kythera Biopharmaceuticals, a company focused on the medical aesthetics market, for $2.1 billion.[16] On November 4 the company announced the acquisition of Northwood Medical Innovation, developer of earFold, a medical device to correct protruding ears.[17] 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.[18]
Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX did not include sufficient numbers o f subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. There were too few patients over the age of 75 to enable any comparisons. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease o r other drug therapy.
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.
Study 1 included 126 patients (64 BOTOX and 62 placebo) with upper limb spasticity (Ashworth score of at least 3 for wrist flexor tone and at least 2 for finger flexor tone) who were at least 6 months post -stroke. BOTOX (a total dose of 200 Units to 240 Units) and placebo were injected intramuscularly (IM) into the flexor digitorum profundus, flexor digito rum sublimis, flexor carpi radialis, flexor carpi ulnaris, and if necessary into the adductor pollicis and flexor pollicis longus (see Table 25). Use of an EMG/nerve stimulator was recommended to assist in proper muscle localization for injection. Patients were followed for 12 weeks.
Baby Botox can also be used as an upkeep strategy. "I really think of it as small maintenance doses of Botox over time instead of standard doses given at three- to six-month intervals," says Smith. "The other term that describes this well is 'tweakment' — subtle changes done over a longer period of time using lower doses of product at each treatment."

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.


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.
The FDA approval was based on a large study showing that Botox significantly reduced migraine frequency and severity, as well as headache-related disability, compared to placebo. As just one measure of its effectiveness, many of my patients report that they’ve cut their use of rescue medications in half since starting Botox – a significant benefit for people who previously had to resort to rescue medications 15 or more times every month.

The median duration of response in study NDO-1 and NDO-2, based on patient qualification for re-treatment was 295-337 days (4248 weeks) for the 200 Units dose group compared to 96-127 days (13-18 weeks) for placebo. Re-treatment was based on loss of effect on incontinence episode frequency (50% of effect in Study NDO-1; 70% of effect in Study NDO-2).

Just because not every cosmetic Botox procedure is FDA-approved doesn't mean it's not safe and effective, if done properly. Off-label procedures are still within the standard of care, and there are tons of them. “There are so many non-FDA-approved applications for Botox,” says dermatologist Dendy Engelman, MD. “It can be used to decrease scalp-sweating (which helps prolong blowouts), correct a droopy nasal tip (called nasal-tip ptosis), fix brow asymmetry, minimize bunny lines from wrinkling your nose, decrease skin oiliness, minimize the appearance of pores...” The list goes on and on.
Migraine with visual aura involves visual effects that usually precede the headache and last at least 5 minutes. The visual aura is usually an expanding blinding spot or visual scintillations (shimmering objects in the visual field). Other aura features include reversible symptoms of speech and language difficulty such as word-finding problems and aphasia (inability to express words or comprehend words), sensory phenomena such as tingling in the extremities extending to the face, motor effects such as weakness, and brainstem problems such as unsteadiness and features of cranial nerve dysfunction. These aura symptoms usually last 5 to 60 minutes, can precede or start during the headache, and can also occur without a headache.
In 1895 (seventy-five years later), Émile van Ermengem, professor of bacteriology and a student of Robert Koch, correctly described Clostridium botulinum as the bacterial source of the toxin. Thirty-four attendees at a funeral were poisoned by eating partially salted ham, an extract of which was found to cause botulism-like paralysis in laboratory animals. Van Ermengem isolated and grew the bacterium, and described its toxin,[40] which was later purified by P Tessmer Snipe and Hermann Sommer.[41]
The idea of a needle going toward your forehead, in between your eyes, or at your eyebrows might be a little daunting, but rest assured, not only is Botox FDA-approved, but it’s a very common (and highly-requested) procedure. It’s commonly used for cosmetic reasons, but it also helps alleviate a slew of other health concerns.”Botox was first approved by the FDA in 1989 to treat blepharospasm of the eyelid, and now can treat hundreds of medical conditions, such as hyperhidrosis (excessive sweating) or chronic migraines,” dermatologist Jill S. Waibel, MD. She also notes that it was only approved for cosmetic purposes in 2002. “Since then, millions of people have had Botox done safely and effectively. It is important to remember that Botox is safest when used by a board certified dermatologist or a plastic surgeon.”

In 1986, Oculinum Inc, Scott's micromanufacturer and distributor of botulinum toxin, was unable to obtain product liability insurance, and could no longer supply the drug. As supplies became exhausted, patients who had come to rely on periodic injections became desperate. For 4 months, as liability issues were resolved, American blepharospasm patients traveled to Canadian eye centers for their injections.[48]
Finding an experienced practitioner is particularly important if you’ve never had Botox treatments before as he or she will devise an optimal treatment plan to address your forehead wrinkles. Furthermore, with an experienced, board-certified plastic surgeon you’ll be far less likely to experience any side effects like pain, bruising around the injection site, droopy eyelids, or mistakenly be administered too much Botox, leaving your face looking frozen for the next several months.

I’ve been getting injections for migraine and cervical dystonia for a couple of years. Thank GAWD for Medicaid to cover it. I went 2 days ago for my 12 week appt. The relief was instantaneous. I’ve been under an immense amount of stress due to losing my only child 5 months ago. I’m still alive and virtually headache free. Botulism…who knew?! But…THANK YOU♡
The median duration of response in study NDO-1 and NDO-2, based on patient qualification for re-treatment was 295-337 days (4248 weeks) for the 200 Units dose group compared to 96-127 days (13-18 weeks) for placebo. Re-treatment was based on loss of effect on incontinence episode frequency (50% of effect in Study NDO-1; 70% of effect in Study NDO-2).
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BOTOX is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) , finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).
In the third study, 25 patients with chronic migraine were injected with 12.5 doses of botox into each trigger point twice, during a period of 3 months. Frequency (main variable), intensity and scales of migraine crises were recorded one month before and one month after the treatment to compare the changes experienced. In addition, side effects were also recorded during the experiment, and they were found to be mild and temporary.
Co-administration of BOTOX® or other agents interfering with neuromuscular transmission (eg, aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
It was peculiar advice coming from a shrink, but not without precedent. In 2014, Rosenthal, a clinical professor of psychiatry at Georgetown University School of Medicine, and Dr. Eric Finzi, an assistant professor of psychiatry at George Washington School of Medicine, published a study showing that when people with major depression got Botox, they reported fewer symptoms six weeks later than people who had been given placebo injections. "I'm always on the lookout for things that are unusual and interesting for depression," says Rosenthal, who is widely considered an expert on the condition. "I've found Botox to be helpful, but it's still not mainstream."
Step therapy is largely unregulated both at the state and federal level, though individual states have started to pass legislation to limit step therapy and protect patients: 19 US states, including California, Mississippi, and Illinois, have laws that require insurance companies to grant certain exemptions or to review appeals from doctors within 72 hours so patients can get a waiver. But even then, getting a waiver isn’t always easy.
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Andrew M. Blumenfeld is director of The Headache Center of Southern California. Most of his research has focused on the use of OnabotulinumtoxinA in the treatment of chronic migraine. He helped develop the injection paradigm approved by the United States Food and Drug Administration and has taught providers around the world on practical aspects of this treatment option.
After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
"There is a difference in pricing based on the duration of the results," says L.A.-based injection specialist Lisa Goodman. (FYI: She's incredible, and I emphatically recommend seeing her if you're in L.A. or Dara Liotta, MD, if you're in NYC.) "The longer-lasting formulas cost more upfront. Shorter-term fillers can last from six to 11 months based on the patient's rate of aging (i.e., smoking, drinking, sun exposure, genetics), while the longer-term fillers last about one to two years."
Aesthetician Mary Schook is anti-Botox because she sees the long-term effects on her clients. “Everyone is always like, ‘Look how great this looks,’ and then there is the long-term and they are like, 'Fix me,'” she says. “Allergan [the company that owns Botox] says one in 100 patients gets eyelid-drop, so I always joke, ‘I must meet one in 100 patients, because everyone I see has that drop.'”
The number of headache days determines whether the patient has episodic migraine (EM) (14 or fewer headache days a month) or CM (more than 15 days of headache a month). The best method of determining the actual number of headache days is to subtract this from the number of completely headache-free days in a month. If headache is present on more than half the days in the month, and there are migraine features on at least 8 days a month, the condition is termed CM. The migraine features only have to be present on 8 days out of the month and not on every headache day. The other headache days in this condition are considered to be milder forms of migraine, and they do not have all the typical migraine features. If headache is present on fewer than 15 days a month, this is referred to as EM. EM can transform to CM over time. If analgesics are used on 10 or more days per month, this can lead to a transformation to CM. The patient’s headache pattern over a 12-month period should be determined, and during this time, there should be at least 3 months with 15 headache days; 8 of these days should meet migraine criteria.1-3
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In just over a decade, the number of people in the U.S. receiving cosmetic botulinum toxin type A injections--mostly from Botox but also from another brand called Dysport, which commands less than 10% of the market--exploded. From 2000 to 2015, use of the toxins for wrinkles increased 759%. It became a cultural phenomenon too, spawning Botox parties, Simpsons jokes, even greeting cards. In 2008, Sex and the City character Samantha famously quipped, "I don't really believe in marriage. Now Botox, on the other hand, that works every time."
In the mid-1990s, people who received BOTOX for other conditions reported improvement in their chronic migraine pain. A two-phase study was conducted, treating patients who averaged 20 headache days a month. They received BOTOX injections every twelve weeks for 56 weeks. At the end of that period, 70% of the patients had fewer than half the number of headaches they had before treatment. The FDA officially approved BOTOX to treat chronic migraine in October of 2010. Since then, more than 100,000 patients have been treated.
On April 6, 2016, the company announced it would partner with Heptares Therapeutics in a deal valued up to $3.3 billion to collaborate on the development of a subtype-selective muscarinic agonists for Alzheimer's disease and other major neurological disorders.[21] On April 21, the company announced the acquisition of Topokine Therapeutics for at least $85 million, gaining the phase IIb/III compound XAF5 - a treatment for dermatochalasis.[22] On August 2, the company sold its generic drugs business to Teva Pharmaceutical Industries for $33.4 billion and 100.3 million shares of Teva.[23] On August 11, the company announced the acquisition of ForSight VISION5 for more than $95 million.[24] On September 6, the company acquired RetroSense Therapeutics for more than $60 million, gaining the positive photosensitivity gene therapy treatment, RST-001. RST-001 is to be used in retinas in which rod and cone photoreceptors have degenerated over time, causing in increase in the sensitivity of light hitting the retina.[25] On September 20, the company announced the acquisition of Tobira Therapeutics for $1.695 billion[26] and, a day later, the acquisition of Akarna Therapeutics for $50 million.[27] On October 3, the company sold Anda, its generic drug distribution business, to Teva for $500 million.[28] On October 25, the company acquired Vitae Pharmaceuticals, focused on dermatology treatments, for $639 million.[29] On October 27, the company announced it would acquire Motus Therapeutics, a developer of treatments for gastrointestinal disorders, for $200 million.[30] On November 22, 2016, the company acquired Chase Pharmaceuticals for an upfront payment of $125 million.[31]
Two double-blind, placebo-controlled, randomized, multi-center, 24-week clinical studies were conducted in patients with OAB with symptoms of urge urinary incontinence, urgency, and frequency (Studies OAB -1 and OAB-2). Patients needed to have at least 3 urinary urgency incontinence episodes and at least 24 micturitions in 3 days to enter the studies. A total of 1105 patients, whose symptoms had not been adequately managed with anticholinergic therapy (inadequate response or intolerable side effects), were randomized to receive either 100 Units of BOTOX (n=557), or placebo (n=548). Patients received 20 injections of study drug (5 units of BOTOX or placebo) spaced approximately 1 cm apart into the detrusor muscle.

In cosmetic applications, botulinum toxin is considered safe and effective for reduction of facial wrinkles, especially in the uppermost third of the face.[23] Injection of botulinum toxin into the muscles under facial wrinkles causes relaxation of those muscles, resulting in the smoothing of the overlying skin.[23] Smoothing of wrinkles is usually visible three days after treatment and is maximally visible two weeks following injection.[23] The treated muscles gradually regain function, and generally return to their former appearance three to four months after treatment.[23] Muscles can be treated repeatedly to maintain the smoothed appearance.[23]
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