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FDA Points Security Alert Concerning Intrathecal Supply of Ache Meds

Posted in News on 15th November 2018

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Dsuvia Accepted for Administration of Acute Ache in Healthcare Settings

Posted in News on 3rd November 2018

November 02, 2018

Dsuvia will not be available in retail pharmacies or for outpatient use

Dsuvia will not be available in retail pharmacies or for outpatient use

AcelRx announced that the Food and Drug Administration (FDA) has approved Dsuvia (sufentanil) sublingual tablets for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours.

The sublingual formulation of sufentanil offers a new treatment option for patients with nothing by mouth (NPO) status and patients with difficult IV access (eg, obese, burn, elderly, needle-phobic patients) to manage acute pain. The single-unit packaging and single-strength sublingual tablets are intended to mitigate the possibility of dosing errors, misuse, and diversion. “Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research.

Dsuvia was evaluated in a randomized, double-blind, placebo-controlled study (N=161) involving patients with acute postoperative pain after abdominal surgery (studied up to 48hrs). Study patients were randomized to Dsuvia 30mcg or placebo as needed with dosing at least 60mins apart; IV morphine sulfate was available as rescue medication. 

The data showed a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared with placebo. The difference in pain intensity from baseline was superior to that of the placebo group within 15 minutes. Also, a smaller proportion of patients in the Dsuvia group took rescue medication within the first 12 hours of the treatment phase, as compared with the placebo group (22% vs 65%). Regarding safety, the most commonly reported adverse reactions were nausea, headache, vomiting, dizziness, and hypotension. 

In a statement, the FDA’s Commissioner Scott Gottlieb, MD, said, “The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise […] I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”

Dsuvia, a Schedule II substance, will be available as 30mcg strength sublingual tablets in a single-dose, pre-filled applicator for administration by a healthcare professional only in certified medically supervised settings. Distribution is expected in the first quarter of 2019 only to healthcare settings certified in the Dsuvia Risk Evaluation Mitigation Strategy (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use.

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For more information call (650) 216-3500 or visit AcelRx.com.

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FDA Committee Votes on First-of-Its-Sort Ache Drug Oliceridine

Posted in News on 14th October 2018
Oliceridine would be the first of a new class of biased ligands with a novel mechanism of action at the mu-opioid receptor

Oliceridine would be the first of a new class of biased ligands with a novel mechanism of action at the mu-opioid receptor

Trevena announced that the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 8-7 against the approval of oliceridine injection for the management of moderate to severe acute pain in adults for whom an intravenous (IV) opioid is warranted.

Oliceridine, a G-protein biased mu-opioid receptor (MOR) ligand, has a unique mechanism of action that allows for more selective pathway activation while avoiding a pathway associated with opioid-related adverse events.

The AADPAC reviewed data from the Phase 3 APOLLO 1 and APOLLO 2 efficacy studies, and from the Phase 3 ATHENA open-label safety study that was designed to reproduce real-world settings in which oliceridine would be used for various surgical and medical acute pain conditions. The data demonstrated all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo. Also, treatment with oliceridine led to comparable pain relief with numerically fewer frequent adverse events (eg, vomiting) when compared with an IV morphine regimen. 

The Prescription Drug User Fee Act (PDUFA) target date has been set for November 2, 2018. The FDA is not bound by the Committee’s recommendation but takes it into consideration when making its decision. If approved, the Company has requested that the drug be classified as a Schedule II controlled substance. 

“We continue to believe that the totality of evidence presented and discussed today supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings,” said Carrie L. Bourdow, President and Chief Executive Officer. “Trevena is committed to working closely with the FDA as they complete their review of the NDA for oliceridine.”

Inveltys Accepted for Publish-Op Ache, Irritation After Ocular Surgical procedure

Posted in News on 27th August 2018
Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Kala announced that the Food and Drug Administration (FDA) has approved Inveltys (loteprednol etabonate) 1% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery. 

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication; other ocular steroids are approved for 4 times daily dosing. Inveltys utilizes the Company’s proprietary Mucus-Penetrating Particle (MPP) technology to improve penetration into target tissues of the eye. The technology has demonstrated a greater delivery of the drug into ocular tissues vs current loteprednol etabonate-containing drugs. 

Data from two Phase 3, multicenter, randomized, double-masked, placebo-controlled trials showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation at Day 8 (24% vs 13%) and Day 15 (50% vs 27%), and complete resolution of pain at Day 4 (43% vs 25%), Day 8 (56% vs 36%), and Day 15 (69% vs 48%) vs placebo (P for both <.01). In addition, treatment was well-tolerated with no treatment-related serious adverse events reported. 

Inveltys will be available as a 1% suspension in 5mL bottles. It is anticipated to launch in the beginning of 2019.

Remedy with L-Glutamine reduces ache in sufferers with sickle cell illness

Posted in News on 28th July 2018

UCSF Benioff Kids’s Hospital Oakland scientific researchers, at the side of different sickle cell facilities and scientists at Emmaus Life Sciences, Inc., have demonstrated that remedy with L-Glutamine decreased the frequency of ache episodes in each pediatric and grownup sufferers with sickle cell illness (SCD). The outcomes of the 48-week, part three scientific trial are revealed within the July 19, 2018, challenge of New England Journal of Drugs (NEJM)

The paper, “A Section three Trial of L-Glutamine in Sickle Cell Illness,” documented the results of taking Endari™, a prescription-grade, pharmaceutical type of L-glutamine, as in comparison with placebo, for 230 sufferers aged 5 to 58 years of age with sickle cell illness. Endari was accredited in July 2017 by the U.S. Meals and Drug Administration based mostly on the security and efficacy knowledge from this examine. Glutamine is an amino acid that’s concerned in a number of biochemical reactions.

The examine confirmed that whether or not administered alone or with hydroxyurea, L-glutamine decreased the frequency of sickle cell ache crises by 25 % (a median of three occasions per affected person within the L-glutamine group and 4 within the placebo group) and hospitalizations by 33 % (a median of two hospitalizations within the L-glutamine group and three within the placebo group). Extra findings confirmed decrease cumulative hospital days of 41 % and a decrease incidence of harmful acute chest syndrome (ACS) by greater than 60 %.

“This examine validated analysis on the security of pharmaceutical grade L-glutamine which has antioxidant properties that improves the NAD redox potential in sickle cell sufferers. Protected neutraceuticals are of main significance to the sickle cell neighborhood,” stated Elliott Vichinsky, MD, Director of Hematology/Oncology on the Northern California Sickle Middle at UCSF Benioff Kids’s Hospital Oakland. “Our scientific trial discovered that L-glutamine, which doesn’t require any routine laboratory monitoring, decreases ache occasions in sufferers by itself or together with hydroxyurea. It’s a main advance in remedy for sickle cell illness and affords households secure, new therapeutic choices.”

Sickle cell illness is a genetic blood dysfunction that causes a distortion within the form of crimson blood cells. This results in the various signs and medical issues affecting youngsters and adults with sickle cell illness, together with ache, anemia, and bone, kidney, lung and neurologic issues.

“Endari, is the primary accredited remedy for sickle cell illness in pediatric sufferers 5 years of age and older and the primary in practically 20 years for adults,” stated examine co-author Yutaka Niihara, MD, CEO and founding father of Emmaus, which produces the product. “Our hope in sharing the outcomes of this knowledge from the New England Journal of Drugs is to extend consciousness of sickle cell illness, a lifelong hereditary blood dysfunction which generally impacts these of African descent, as effectively these from Central and South America and other people of Center Jap, Asian, Indian and Mediterranean descent. It will be important for sufferers to know that they’ve a remedy possibility for this debilitating illness.”

The double-blind trial evaluated the efficacy and security of pharmaceutical-grade L-glutamine administered twice every day by mouth, as in contrast with placebo, in decreasing the frequency of ache crises amongst sufferers with sickle cell anemia or sickle βzero-thalassemia and a historical past of two or extra ache crises through the earlier 12 months. Sufferers who have been receiving hydroxyurea at a dose that had been steady for no less than three months earlier than screening continued that remedy by way of the 48-week remedy interval.

Sufferers have been randomly assigned, in a 2:1 ratio, to obtain L-glutamine (152 sufferers) or placebo (78 sufferers). These within the L-glutamine group had considerably fewer ache crises than these within the placebo group (P = zero.005) and fewer hospitalizations (P = zero.005). Roughly 54 % of the sufferers have been feminine and 66 % of the sufferers in each trial teams have been already receiving hydroxyurea. The examine discovered that low-grade nausea, non-cardiac chest ache, fatigue and musculoskeletal ache occurred extra steadily within the L-glutamine group than within the placebo group.

Supply:

https://www.ucsf.edu/information/2018/07/411221/new-study-shows-l-glutamine-decreases-sickle-cell-pain-crises-hospitalizations