Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. The firm offers products under the following brands: BOTOX, Juvederm, Linzess, Namenda, Restasis, Latisse, Teflaro, Lo Loestrin Fe, Bystolic, DORYX, Saphris, Fetzima, Namenda XR, Namzaric, Viberzi, Viibryd, Alphagan, LUMIGAN, ESTRACE Cream, Rapaflo, Asacol, DELZICOL, Zenpep, Avycaz, and Dalvance. Its brand portfolio delivers treatments that address unmet medical needs in therapeutic categories such as dermatology and aesthetics;Read More
Botox is mostly performed in a medical setting and is known to be a quick and painless medical procedure.The skin is cleansed with alcohol or another antiseptic and a topical anesthetic ointment is applied to the skin. After ten minutes the physician or nurse injects Botox or disport with a very fine needle. The procedure should be almost painless and takes only takes about 15 minutes to perform. You can easily walk out of the office and resume your daily activities.The effect of Botox or Dysport will usually take 48 to72 hours before you see the results.
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.
Botulinum toxin (BTX) is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis. Infection with the bacterium causes the disease botulism. The toxin is also used commercially in medicine, cosmetics and research.
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®.
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.
The efficacy and safety of BOTOX for the treatment of primary axillary hyperhidrosis were evaluated in two randomized, multi center, double-blind, placebo-controlled studies. Study 1 included adult patients with persistent primary axillary hyperhidrosis who scored 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS) and who produced at least 50 mg of sweat in each axilla at res t over 5 minutes. HDSS is a 4-point scale with 1 = “underarm sweating is never noticeable and never interferes with my daily activities”; to 4 = “underarm sweating is intolerable and always interferes with my daily activities”. A total of 322 patients were randomized in a 1:1:1 ratio to treatment in both axillae with either 50 Units of BOTOX, 75 Units of BOTOX, or placebo. Patients were evaluated at 4-week intervals. Patients who responded to the first injection were re-injected when they reported a re-increase in HDSS score to 3 or 4 and produced at least 50 mg sweat in each axilla by gravimetric measurement, but no sooner than 8 we eks after the initial injection.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
The following adverse reactions have been identified during post-approval use of BOTOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: abdominal pain; alopecia, including madarosis; anorexia; brachial plexopathy; denervation/muscle atrophy; diarrhea; hyperhidrosis; hypoacusis; hypoaesthesia; malaise; paresthesia; peripheral neuropathy; radiculopathy; erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption; strabismus; tinnitus; and visual disturbances.
“We don’t believe Botox is expensive when you look at the value that we provide,” says Marc Forth, senior vice president of US marketing at Allergan, the maker of Botox. Botox halves migraine days in 50 percent of patients who get the injections, Forth says. “We believe that value is worth the tradeoff.” Allergan doesn’t have a say on step therapy policies. Insurers “ultimately make that call on their own,” Forth says.
Firstly, that is one of the most popular combination of areas for Botox treatment in my office. Like others on this panel, I happen to think the fairest method for charging for Botox is by the unit. Botox can only be purchased through Allergan here in the United States and comes in a 100 unit bottle typically. The only common denominator between offices is how many units of Botox are you... READ MORE
Most people tolerate the injection discomfort well. But you may want your skin to be numbed beforehand, especially if your palms or soles are being treated for excessive sweating. Your doctor might use one or more of various methods available to numb the area, such as topical anesthesia, ice and vibration anesthesia, which uses massage to reduce discomfort.
According to the PREEMPT injection paradigm, a total of 5 units of onabotulinumtoxinA is injected into each corrugator muscle. To confirm the location of the muscle, the patient is asked to furrow the brow in order to activate the corrugator. Once the muscle has been located, the muscle should be palpated and pinched by holding it between the thumb and index finger. Five units of onabotulinumtoxinA is injected at an approximate 90° angle with the bevel of the needle pointing upward into the medial belly of the muscle. As the needle is inserted, there is skin resistance, which lessens when the muscle is penetrated. This decrease in resistance is termed a muscle pop. Once the muscle pop occurs, inject into the superficial muscle. If the injection is too far superior or above the corrugator muscle, brow ptosis can occur due to depression of the medial brow as the frontalis elevating function is lost and the corrugator depressing function remains unopposed. Whereas weakening the corrugator muscle will cause elevation of the medial eyebrow, alternatively, if the corrugator injection is done too low, then diffusion to the levator palpebral muscle could lead to lid ptosis.
The cost of a Botox treatment is usually communicated as a flat cost, but can also be measured in individual injectable units. Each unit usually costs somewhere in the neighborhood of $15, but prices vary between geographic areas and between individual clinics. How many units are needed per treatment will depend on which areas of your face are being treated, and on your individual facial anatomy.
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
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.