Category: drugs

Jul 05

What You Need to Know About a Promising New Alzheimer’s Drug

What You Need to Know About a Promising New Alzheimer’s Drug Plaques in the brain are a hallmark of Alzheimer’s disease, and the investigational drug aducanumab, which is now sold under the brand name aduhelm, has demonstrated some promise in this regard. Memory loss and cognitive decline are thought to be caused, at least in part, by these plaques, which are made of amyloid-beta protein. According to the findings of certain studies, the levels of these plaques in the brain can be lowered by treatment with aducanumab. It is essential to keep in mind, however, that a reduction in the number of plaques does not always promise either an improvement in brain function or a halt in the advancement of the illness. In the clinical tests that have been carried out up until this point, the effectiveness of the medicine in enhancing cognitive capacities or halting the progression of Alzheimer’s disease has not been demonstrated in a way that can be considered definitive. In order to have a complete understanding of the possible advantages and hazards of Aducanumab as a therapy for Alzheimer’s, more study is required. Although the preliminary research results are encouraging, it will be several more years before aducanumab may be utilized in a clinical setting as a potential therapy for Alzheimer’s disease. For the sake of determining its efficacy and safety, more research, including clinical tests conducted on a larger scale, is required. What can cause Alzheimer’s disease? Alzheimer’s disease, the specific origin of which is still unclear, has been linked to the production of amyloid-beta plaques in the brain, which can take place years before cognitive symptoms manifest themselves. However, the mere appearance of plaques is not sufficient evidence that memory issues exist, which adds another layer of complication to the condition. However, the majority of pharmacological research has been directed toward targeting these plaques in order to find possible remedies. It’s possible that the Massachusetts-based business Biogen has made some headway in this area. In a clinical trial that lasted for 54 weeks, they gave varying dosages of their medication aducanumab to 125 patients who were in the early stages of Alzheimer’s disease. The infusions were given intravenously on a monthly basis. Aducanumab is a monoclonal antibody, which means it is a molecule that was generated in the lab that resembles human immune system proteins. In addition, there were forty patients who were given placebo infusions as part of the trial. Brain scans taken at the end of the research showed that individuals who had been given the medicine had much lower amounts of plaque in their brains compared to when the study had first begun. The highest dose produced results that were almost identical to plaque removal. Patients who were given a placebo, on the other hand, had few alterations in the brain plaques they had. Plaque and Alzheimer’s Additionally, the decrease in plaques that was identified in the research may have been a factor in the slower progression of Alzheimer’s symptoms. According to Roger M. Nitsch, MD, co-author of the study and head of the Institute for Regenerative Medicine at the University of Zurich, patients who received the antibody had more stable cognitive abilities than those who received the placebo. Cognitive questionnaires were employed to measure the participants’ cognitive ability, even though the purpose of the study was not to establish the efficacy of the treatment being investigated. The executive director of the Banner Alzheimer’s Institute in Phoenix, Eric M. Reiman, MD, believes that this discovery is of great relevance. Dr. Reiman, who was not involved in the research but wrote a commentary that accompanied the research and was published in the journal Nature, described the findings as "unusually striking" and supportive of the theory that plaque plays a role in the development of Alzheimer’s symptoms. The opinion was published with the research. According to Dr. Reiman, this might represent a substantial step in the battle against Alzheimer’s disease if the first cognitive findings are validated in bigger and more comprehensive clinical trials, which are already under way. These trials are currently being conducted. However, he emphasizes that even while the new cognitive findings are intriguing, it is important to remember that they are not conclusive. Before reaching any definitive conclusions on the effectiveness of aducanumab and other treatments of a similar kind in treating symptoms such as memory loss, the whole cognitive benefit of aducanumab and other drugs of this kind has to be evaluated in the bigger trial. The Clinical Trial The findings of Biogen’s study were derived from a phase 1b clinical trial, which is an early stage of research that only involved a limited number of human participants. These preliminary investigations have shown some encouraging findings; nevertheless, more extensive phase II and phase III clinical trials are required to validate the drug’s safety and efficacy, as well as to get regulatory permission for its usage by the general public. Some of the people who took part in the experiment ended up dropping out because they were suffering from headaches and a buildup of fluid in their brains. The authors of the study recognise the significance of taking into account the possibility of adverse consequences. It is essential to keep in mind that a significant number of Alzheimer’s medications that have showed promise in earlier phases of development have eventually shown to be unsuccessful in subsequent tests. The antibody known as aducanumab is presently the subject of additional research in the form of two ongoing clinical studies with a total participant pool of roughly 2,700 people. Although these early findings represent an essential first step, Dr. Nitsch is optimistic that they will pave the way for more substantial advancements in the future. This opinion is echoed by Dr. Reisman, who also underlines the importance of conducting more study to determine whether or not a plaque-reducing medicine can successfully reduce the progression of cognitive impairment. He feels that such confirmation would be a revolutionary step forward in comprehending Alzheimer’s

Sep 05

Is Adderall in Short Supply? Challenges: What You Need to Know Taking the ADD Drugs

The FDA reported a shortage of Adderall, a medicine used to treat attention-deficit/hyperactivity disorder (ADHD). The announcement follows weeks of complaints from customers and pharmacists about difficulties obtaining the medication. This is the second time in recent years that the government agency has recognized a scarcity of Adderall, also known as amphetamine mixed salts pills. The FDA detected a shortage in September of 2019, but by May of 2022, the problem had been remedied. Aurobindo Pharma, Lannett Company, Milan Pharmaceuticals, Sandoz, and Teva Pharmaceuticals were the five drug manufacturers hit by the Adderall shortage. Teva, one of these pharmaceutical firms, is suffering manufacturing delays that are generating the current shortage, as was indicated in the FDA’s press statement reinstating the formal shortage. In September, an FDA spokeswoman assured Health that the agency still anticipated having sufficient supply to fulfill demand, despite the difficulties that Teva would be experiencing over the following months. The agency, however, now claims that rival producers are falling behind. The FDA noted in a news statement that while “other manufacturers continue to produce amphetamine mixed salts,” their output is insufficient to fulfill the current demand in the United States. Teva, the leading U.S. supplier of both original and generic Adderall, acknowledged delays of the medicine in September and stated that they should be temporary. A representative for Teva, Kelly Dougherty, told Health that while certain customers “may encounter a backorder (intermittently) based on timing and demand,” such delays are usually short-lived. “We are actively shipping both branded and generic Adderall to customers,” the company said, adding that “we expect full recovery for all inventory and orders in the coming weeks, at which point we expect no disruption at the pharmacy level.” Before the announcement on Wednesday, doctors and patients have been sounding the alarm in interviews with media sites including BuzzFeed News, Bloomberg, and NBC News about the difficulty of maintaining enough supplies of Adderall. Sixty-four percent of community pharmacists surveyed by the National Community Pharmacists Association in August said they had trouble getting Adderall in for their patients. The FDA has verified the accounts of patients and clinicians, yet many still have trouble getting their hands on life-changing medications. What you need to know about buying Adderall and what to do if you run across problems doing so are detailed below. Increased demand complicates already challenging supply conditions. Limited availability of the medicine was reportedly caused by a manpower shortfall at Teva, as reported by Bloomberg. Dougherty stated that there is “no product shortage on our end,” and that “any noted delays are the downstream effect of a past labor shortage on the packaging line which has since been resolved.” More people using Adderall at the same time has led to shortages in recent years. The use of amphetamines like Adderall was already on the rise before to the COVID-19 epidemic, with consumption tripling between 2006 and 2016; nevertheless, the pandemic accelerated the trend. Iqvia Holdings found that prescriptions for Adderall climbed by more than 10% between 2020 and 2021 as a result of lockdowns, and that the number of telemedicine visits, especially those dealing with mental health difficulties, increased. The New York Times noted that several of the start-up businesses that began offering telemedicine mental health services during the epidemic, such as Cerebral Inc. and Done Global Inc., have come under fire for potentially overprescribing the ADHD medicines. In May, Cerebral announced that they will “indefinitely” discontinue dispensing restricted medications including Adderall, Ritalin, and others. The Wall Street Journal states that the U.S. Drug Enforcement Administration (DEA) is also looking into the prescription procedures of Done. If Your Pharmacy Is Out of Your Medications, What to Do The best way to avoid having to go without Adderall is to get your prescription refilled as soon as possible. “That way you have time to find another pharmacy that stocks your medication if your usual pharmacy is out-of-stock,” Farah Khorassani, PharmD, associate clinical professor at the University of California, Irvine School of drugstore & Pharmaceutical Sciences told Health. If your pharmacy is out of Adderall, Khorassani suggests calling around to other pharmacies in the area, or having your pharmacist do so on your behalf. Alex Dimitriu, MD, founder of Menlo Park Psychiatry & Sleep Medicine and BrainfoodMD, advised checking into mobile or mail-order pharmacies if your regular drugstore was out of stock. According to Sonia Gaur, MD, a psychiatrist at Stanford Health Care, you may wish to urge your healthcare physician to phone your prescription into a new pharmacy. If the drug becomes increasingly difficult to obtain due to the shortage, you and your doctor may want to consider switching to a different type of stimulant prescription. As part of its shortage statement, the FDA suggested that patients who were unable to obtain Adderall consult with their doctors about using other forms of medication, such as extended-release forms of amphetamine mixed salts. However, because withdrawal symptoms from stopping Adderall or any other medicine can be severe, it’s not a good idea to do so without first consulting a doctor. According to Guar, “the risk profile is based on multiple factors,” including “comorbid diagnoses,” “length of taking medications,” and “medication dose.” In addition to affecting your energy and mood, abruptly changing your drug regimen may cause you to feel more exhausted and hungry than normal. Dr. Dimitriu says that fortunately, you should only have these symptoms for approximately a week. If you forget to refill your prescription in time and run out of medicine, Dr. Dimitriu advises starting with a lesser dosage and gradually building back up. If you have tried everything and can’t find your medication, talk to your doctor about other possibilities and make getting enough sleep a top priority. “Sleep is essential to ADHD and our attention, focus, and impulse control,” Dr. Dimitriu stated, “so make sure you keep sleeping well (over seven hours) whether on meds or off.”