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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.


Section three examine of tanezumab in sufferers with osteoarthritis ache meets all three co-primary endpoints

Posted in News on 22nd July 2018

Pfizer Inc. and Eli Lilly and Firm at present introduced 16-week Section three examine in sufferers with osteoarthritis (OA) ache evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The examine demonstrated that sufferers who obtained two doses of tanezumab separated by eight weeks skilled a statistically vital enchancment in ache, bodily operate and the sufferers’ total evaluation of their OA, in comparison with these receiving placebo. Tanezumab is a part of an investigational class of ache drugs often called nerve development issue (NGF) inhibitors and along with OA ache, is being evaluated for persistent low again ache (CLBP) and most cancers ache (as a consequence of bone metastases).

“There’s a substantial want for progressive new therapy choices for osteoarthritis, as many sufferers are unable to seek out reduction with presently obtainable medicines and proceed to endure,” stated Ken Verburg, tanezumab growth group chief, Pfizer International Product Growth. “We’re inspired by these outcomes, which converse to the potential of tanezumab as a non-opioid therapy possibility for ache discount and enchancment in bodily operate in individuals dwelling with osteoarthritis ache.”

Preliminary security information confirmed that tanezumab was typically nicely tolerated, with roughly 1% of sufferers discontinuing therapy as a consequence of antagonistic occasions. Quickly progressive osteoarthritis was noticed in tanezumab-treated sufferers at a frequency of lower than 1.5%, and was not noticed within the placebo arm. There have been no occasions of osteonecrosis noticed within the trial. No new security indicators have been recognized.

“Worldwide, hundreds of thousands live with osteoarthritis, a progressive illness that may considerably impression individuals’s on a regular basis lives,” stated Christi Shaw, senior vp, Eli Lilly and Firm and president, Lilly Bio-Medicines. “We look ahead to persevering with to advance tanezumab in our ongoing international Section three growth program, which incorporates six research in roughly 7,000 sufferers with osteoarthritis, persistent low again ache and most cancers ache.”

In June 2017, Pfizer and Lilly introduced that the U.S. Meals and Drug Administration (FDA) granted Quick Observe designation for tanezumab for the therapy of OA ache and CLBP. Tanezumab is the primary NGF inhibitor to obtain Quick Observe designation, a course of designed to facilitate the event and expedite the assessment of latest therapies that deal with severe circumstances and fill unmet medical wants.


Posted in: Drug Trial Information | Medical Situation Information

Tags: Dependancy, Antibody, Anti-Inflammatory, Again Ache, Biopharmaceutical, Bone, Mind, Most cancers, Scientific Trial, Shopper Well being, Medicine, Frequency, Well being Care, Healthcare, Irritation, Knee, Monoclonal Antibody, Nerve, Opioids, Osteoarthritis, Osteonecrosis, Ache, Pfizer, Placebo, Analysis, Pores and skin

Are Anticonvulsants Efficient for Low Again Ache?

Posted in News on 5th July 2018

July 03, 2018

Use of anticonvulsant therapy for LBP has been on the rise

Use of anticonvulsant remedy for LBP has been on the rise

Anticonvulsants seem like ineffective within the therapy of low again ache (LBP) and could also be related to an elevated threat for adversarial occasions, in accordance with a research printed within the Canadian Medical Affiliation Journal.

Nonpharmacologic interventions and nonopioid analgesics are typically really useful in medical pointers for the therapy of LBP, however the usage of anticonvulsants, particularly gabapentinoids, has been growing in accordance with latest stories. “Clinically, the prescription of anticonvulsants for again and neck ache, together with radicular ache in major care, has elevated by 535% within the final 10 years,” write the authors of this systematic evaluation and meta-analysis, “This pattern could also be because of prescribers looking for a substitute for opioids.”

For this evaluation, the authors searched 5 massive databases for research that in contrast the usage of anticonvulsants (i.e., topiramate, gabapentin, pregabalin) in grownup sufferers with LBP, sciatica, or neurogenic claudication with placebo. They had been in a position to determine 9 placebo-controlled research which examined the consequences of those anticonvulsants for LBP and lumbar radicular ache in 859 sufferers.

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The outcomes confirmed that anticonvulsants had been discovered to be ineffective at lowering ache or incapacity related to LBP or lumbar radicular ache in 14 of the 15 comparisons. Excessive-quality proof demonstrated that gabapentinoids had no impact on continual LBP vs placebo within the quick time period (pooled imply distinction [MD] -Zero.Zero, 95% CI -Zero.eight to Zero.7); the identical was famous for lumbar radicular ache within the intermediate time period (pooled MD -Zero.1, 95% CI -Zero.7 to Zero.5). Nonetheless, the authors did discover that use of gabapentinoids was related to an elevated threat of adversarial occasions (high-quality proof). 

With regard to topiramate, a small medical impact on ache was famous within the quick time period, however there was no impact on incapacity (moderate-quality proof) and really low-quality proof confirmed that use was not related to an elevated threat of negative effects.

Primarily based on the findings from this systematic evaluation the authors concluded that “proof thus far doesn’t help the usage of anticonvulsants for continual low again ache or lumbar radicular ache.”

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Consensi Authorised to Deal with Hypertension and Osteoarthritis Ache

Posted in News on 3rd June 2018

June 01, 2018

Consesni is only available in a celecoxib strength of 200mg and is only taken once daily

Consesni is simply obtainable in a celecoxib power of 200mg and is simply taken as soon as each day

Kitov Pharma introduced that the Meals and Drug Administration (FDA) has accredited Consensi (amlodipine and celecoxib) for sufferers with osteoarthritis ache and hypertension.

Consensi combines amlodipine besylate, a calcium-channel blocker (CCB), and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID). The mix of celecoxib and amlodipine was studied in a randomized, double-blind, placebo- and active-controlled research in 152 sufferers with newly identified hypertension who required pharmacological remedy to regulate their hypertension. The trial used celecoxib capsules and amlodipine tablets that had been individually over-encapsulated after which taken collectively or with matching placebos. Sufferers had been randomized to 1 of four therapy arms: celecoxib 200mg + amlodipine 10mg, amlodipine 10mg, celecoxib 200mg or placebo; all remedies got as soon as a day for 14 days. Outcomes confirmed that the mixture of celecoxib and amlodipine supplied comparable blood strain discount to an equal dose of amlodipine. 

With regard to osteoarthritis, no research of the mixture of celecoxib and amlodipine have been carried out to point a discount in indicators and signs, nonetheless celecoxib alone has demonstrated these results in different scientific trials. There are additionally no long-term research to judge cardiovascular security for this mix.

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“We consider that Consensi, as a single tablet mixture therapy for osteoarthritis and hypertension, presents a singular worth proposition of doubtless growing therapy adherence,” said Kitov’s CEO, Isaac Israel.

Consensi carries a Boxed Warning relating to the danger of great cardiovascular and gastrointestinal occasions. Remedy is contraindicated within the setting of coronary artery bypass graft (CABG) surgical procedure. If analgesic remedy is not indicated, Consensi ought to be discontinued and sufferers ought to be initiated on various antihypertensive remedy.

Consensi will probably be obtainable in 2.5mg/200mg, 5mg/200mg, and 10mg/200mg power tablets in 100- and 500-count bottles. 

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