FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression – Drug for nerve pain boosts high for opioid abusers.

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FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). This is the first new mechanism of action in 3 decades to treat major depressive disorder (MDD).1,2

The approval follows a phase 3 clinical trial with more than 1700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at 4 weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.

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FDA Commissioner Announces His Resignation From the Agency – APhA submits compounding comments to FDA.

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FDA Commissioner Announces His Resignation From the Agency – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA Commissioner Scott Gottlieb, MD, has resigned from the agency, and will vacate his role in the next month.

In a letter to colleagues that was publicly shared on the FDA’s Twitter account, Gottlieb said that he was “missing” his family. He cited the challenge of being apart from his his wife and 3 young children as the reason for his depature. He did not further elaborate.

“I’m grateful for the support of my family, and for their sacrifice over the past 2 years,” Gottlieb wrote.

Gottlieb also used the letter to reflect on last few years that he has spent as commissioner of the agency.

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Advocacy Group Seeks Personal Injury Lawyers for People Injured by Pharmacy Errors – Drug for nerve pain boosts high for opioid abusers.

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Advocacy Group Seeks Personal Injury Lawyers for People Injured by Pharmacy Errors – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The consumer advocacy group US Drug Watchdog is publicly seeking personal injury lawyers to assist people injured by pharmacy errors in the United States’ top 100 metro areas.

In a statement, the group said it conducted a half-year investigation into pharmacies dispensing prescriptions to the wrong people, and has found that a significant enough problem exists nationwide to warrant the action.

“The reason we are inviting top 100 US metro area local lawyers/law firms to assist with our pharmacy prescription errors consumer initiative on a metro specific basis is because in cases where the pharmacy error most frequently encountered in a big metro area, the ER visit or hospitalization occurred in a big metro area, and the victim will need a capable personal injury lawyer or law firm to assist them in the same metro area,” the group said, in a press release.

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Health Systems Share Their Approaches to Improve Patient Engagement – APhA submits compounding comments to FDA.

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Health Systems Share Their Approaches to Improve Patient Engagement – APhA submits compounding comments to FDA. – (866) 348-2889.

Health systems are actively developing consumer technologies to help patients better manage their health, and a recent report involving several of these health systems revealed some novel ways to accomplish this goal.  Using patient-centered health care technologies, these health sytems were able to deliver positive measurable outcomes for patients, researchers reported in the March issue of Health Affairs.

In one example cited in the paper, officials with Ochsner Health System reported using their online patient portal to help treat hypertension with a novel digital medicine program that combined patient-reported blood pressure data, clinical data, and coaching.  Outcomes showed that medication adherence among patients improved 14% while 79% achieved greater blood pressure control. Overall, clinicians saw a 29 percent reduction in clinic visits.

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Survey: Women Want Information on PrEP – Drug for nerve pain boosts high for opioid abusers.

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Survey: Women Want Information on PrEP – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Many women are unaware of HIV pre-exposure prophylaxis (PrEP) but show a keen interest in spreading the word once they learn about the option, according a recent study in the journal Contraception.

The study included 500 women at 4 family planning clinics in Atlanta, and included an HIV risk screener before the patients visited with a provider, followed by questions about their counseling afterward.

According to the study, 18% of women surveyed knew about PrEP and 28% of the 376 who were sexually active had a risk indicator placing them within the recommended range for PrEP. Georgia ranks 3rd highest for lifetime HIV risk, the study noted, adding that 56% of women diagnosed in 2015 were living in the south.

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Adhansia XR Gets FDA Nod for ADHD Treatment – APhA submits compounding comments to FDA.

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Adhansia XR Gets FDA Nod for ADHD Treatment – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the FDA have approved methylphenidate hydrochloride (Adhansia XR, Adlon Therapeutics) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.

The drug’s approval was based on 4 clinical studies evaluating the efficacy and safety of Adhansia XR in 883 people who met DSM-5 criteria for ADHD. While receiving Adhansia XR, adults achieved statistically significant improvement over placebo, achieving greater mean Permanent Measure of Performance Total (PERMP-T) scores averaged across all time points on simulated Adult Workplace Environment (AWE) days (post-dose score of 281.3 vs. 254.5; difference of 26.80, 95% CI [15.19, 38.41]). The secondary efficacy endpoints were onset and duration of clinical effect, as assessed by the treatment difference in PERMP-T scores at post-dose time points. Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.1

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New Research May Lead to a Universal Flu Vaccine – Drug for nerve pain boosts high for opioid abusers.

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New Research May Lead to a Universal Flu Vaccine – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

New research out of Australia is raising the hope that scientists might soon be able to develop a 1-time vaccine that would provide long-term protection against all types of the flu.

The research centers on CD8+ T cells, which can recognize and attack the influenza virus. These cells have already been known to provide cross-protection against strains of Influenza A. However, to date there has been little evidence regarding the extent to which CD8+ T cells could also provide protection against B and C strains of the flu.

The investigators had previously found that CD8+ T cell response was in many cases the difference between life and death among patients infected by the H7N9 avian flu in China back in 2013. Those with strong CD8+ T cell responses tended to recover relatively quickly; those with low levels of the cells often died.

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Subcutaneous Herceptin Combo Therapy for Certain Breast Cancer Patients Granted FDA Approval – APhA submits compounding comments to FDA.

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Subcutaneous Herceptin Combo Therapy for Certain Breast Cancer Patients Granted FDA Approval – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with the FDA have approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) subcutaneous injection for certain patients with HER2-positive early and metastatic breast cancer, according to a press release.

Trastuzumab and hyaluronidase-oysk is indicated for patients with early disease in combination with chemotherapy, and metastatic disease in combination with paclitaxel, or alone in patients who have received 1 or more chemotherapy regimens.

This subcutaneous treatment includes the same monoclonal antibody as intravenous trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin, according to Genentech. Trastuzumab and hyaluronidase-oysk is a ready-to-use formulation that can be administered in 2 to 5 minutes.

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Study Shows Pharmacists Can Increase Hormonal Contraceptive Adherence – Drug for nerve pain boosts high for opioid abusers.

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Study Shows Pharmacists Can Increase Hormonal Contraceptive Adherence – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A survey of sexually active women in the United States revealed that 29% experienced challenges in obtaining either a prescription or a refill for hormonal contraception. As medication experts and highly trusted professionals, pharmacists can help decrease patient barriers to adherence in the community-based pharmacy setting.

The journal Contraception has published a study showing that pharmacists in California and Oregon are serving as an access point for hormonal contraception services and supplies for diverse patient populations. The descriptive study included 391 community-based pharmacies in which a total of 2117 visits were completed over a 6-month period.

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Researchers: Gene Involved in ADHD Could Be Related to Addictive Substance Use – APhA submits compounding comments to FDA.

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Researchers: Gene Involved in ADHD Could Be Related to Addictive Substance Use – APhA submits compounding comments to FDA. – (866) 348-2889.

An international study of around 2,700 children, adolescents, and adults has demonstrated that some variations in the gene LPHN3, which is associated with attention deficit/hyperactivity disorder (ADHD), could favor likelihood to smoke, consume alcohol, cannabis and other addictive substances, according to an article published in the journal Translational Psychiatry.

The study, led by researchers from the National Institutes of Health, was conducted in the United States, Colombia, and Spain, and it will likely contribute to provide new genetic tools to improve prevention of addictive behaviors in people with ADHD.

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