Gralise (gabapentin) / Alvogen - LARVOL DELTA

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Alliance for Clinical Trials in Oncology

New P3 trial • Head and Neck Cancer • Mucositis • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Stomatitis

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery (clinicaltrials.gov) - P4 | N=110 | Completed | Sponsor: Joseph Kowalski | Recruiting ➔ Completed

Trial completion

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery (clinicaltrials.gov) - P4 | N=110 | Recruiting | Sponsor: Joseph Kowalski | Enrolling by invitation ➔ Recruiting

Enrollment status • Surgery

A Single-Institution Experience of Acute Neuropathic Lumbosacral Pain in Patients Treated with Short Course Hypofractionated Radiotherapy in Locally Advanced Rectal Cancer - P=NA | N=75 | "We have identified a previously underappreciated acute toxicity of neuropathic lumbosacral pain in short course hypofractionated radiation therapy, which may be due to a lumbosacral plexus toxicity. Further analysis will seek to identify predictive factors such as comorbidities and dose to the lumbosacral plexus, and to determine whether there is a correlation between these observed acute toxicities and long-term outcomes."

Clinical data • Journal

Lamex and Adalvo collaborate to launch Gabapentin ER, a daily medication for postherpetic neuralgia in South Korea [Google translation] (stock.yahoo) - "Lamex...and Adalvo...announced that two dosage forms of the jointly collaborated post-herpetic neuralgia drug Gabapentin ER 300mg and 600mg have been officially launched in South Korea. This 505b(2) drug is a sustained-release formula developed based on Neurontin capsules 300 mg and Neurontin film-coated tablets 600 mg. It is used to provide long-lasting relief to patients with post-herpetic neuralgia (PHN)....Gabapentin ER was reviewed and approved by the South Korean Food and Drug Administration (MFDS) in March 2023, and was officially launched in South Korea through the close cooperation between Lamex and Adalvo."

Launch non-US • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery (clinicaltrials.gov) - P4 | N=110 | Enrolling by invitation | Sponsor: Joseph Kowalski | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Surgery

Lotus Announces MFDS Approval for GRALISE SR, Once-Daily Tablets for Post-Herpetic Neuralgia (Market Screener) - "Lotus Pharmaceuticals...has announced the approval of GRALISE, a once-daily Gabapentin extended-release tablet, by the Ministry of Food and Drug Safety of Korea. This marks the first sustained release formulation of Gabapentin approved in Korea for the treatment of Post-Herpetic Neuralgia (PHN)....The treatment offers enhanced convenience to patients compared to conventional immediate-release forms of Gabapentin."

Non-US regulatory • CNS Disorders • Neuralgia • Pain

Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Massachusetts General Hospital | N=30 ➔ 0 | Unknown status ➔ Withdrawn

Enrollment change • Trial withdrawal • Pain

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery (clinicaltrials.gov) - P4 | N=110 | Not yet recruiting | Sponsor: Joseph Kowalski

New P4 trial • Surgery

"Full dose Gralise took the edge off 4 me but only for a few hours My sister finally figured out gabapentin was making her dog psychotic- literally. Went to dog behaviorist and it was beyond them. Almost euthanized. Stopped gabapentin and dog became normal" (@Ninablake6789)

CNS Disorders

Recent Advances in Multiple Myeloma: Insights from Experts at Dana Farber Cancer Institute and Massachusetts General Hospital - Episode 5: Patient Profile 2: A 72-Year-Old With Transplant-Ineligible NDMM (Cancer Network) - "Noopur Raje, MD: I'm going to move on to the next case. Omar, you have an interesting case for us in the transplant-ineligible patient population....Noopur Raje, MD: Omar, you described it so well, was it cycle 74? Unbelievable. That's amazing that the patient was able to continue treatment for that long."

Video

Managing ADT-related adverse events: An expert’s view (Urology Times) - ''It's important to recognize that there has been a shift in the way we approach ADT,' says David F. Jarrard, MD....In this interview, David F. Jarrard, MD, discusses new data regarding adverse events and how they are best managed."

Interview

Can Pickle Juice Help Ease Cirrhotic Cramps? (Medscape) - "'The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,' lead investigator Elliot Tapper, MD...'This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,' Tapper said....Paul Martin...noted that, while muscle cramps can have a major impact on quality of life, 'in terms of some of the other complications of cirrhosis that healthcare providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.'"

Media quote

Nonopioid drugs for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Neuralgia • Osteoarthritis • Pain • Rheumatology

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (clinicaltrials.gov) - P=N/A; N=62; Completed; Sponsor: Roswell Park Cancer Institute; Active, not recruiting ➔ Completed; Trial completion date: Apr 2022 ➔ Nov 2021

Clinical • HEOR • Trial completion • Trial completion date • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (clinicaltrials.gov) - P=N/A; N=62; Active, not recruiting; Sponsor: Roswell Park Cancer Institute; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • HEOR • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (clinicaltrials.gov) - P3; N=79; Completed; Sponsor: Vanderbilt-Ingram Cancer Center; Active, not recruiting ➔ Completed

Clinical • Trial completion • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial completion date: May 2021 ➔ Feb 2022

Clinical • HEOR • Trial completion date • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

[VIRTUAL] Drug utilization evaluation report for the use of gabapentin and pregabalin at CHI Franciscan (ASHP 2020) - "Purpose: Gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) are FDA approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome...Common opioids were oxycodone, morphine and hydrocodone. Benzodiazepines included diazepam, alprazolam, and clonazepam. Antidepressants noted were mirtazapine, sertraline, escitalopram, and bupropion. Lastly, antipsychotics such as aripiprazole, haloperidol, olanzapine, quetiapine, risperidone, and valproic acid were observed...Benzodiazepine combinations yielded the highest mortality rate of 36%, followed by opioid combinations and cyclobenzaprine, 32% and 30% respectively... Gabapentinoids taken with CNS depressants should be monitored. Patients will be at high risk of developing respiratory depression or increased risk of opioid overdose death. Best safety practices involve initiating gabapentinoids at the lowest dose and providing education to patients to recognize signs and..."

Addiction (Opioid and Alcohol) • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Epilepsy • Immunology • Movement Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry • Renal Disease • Respiratory Diseases • Restless Legs Syndrome • Sleep Disorder

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • HEOR • Trial primary completion date • Head and Neck Cancer • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (clinicaltrials.gov) - P3; N=79; Active, not recruiting; Sponsor: Vanderbilt-Ingram Cancer Center; Trial completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery (clinicaltrials.gov) - P3; N=10; Terminated; Sponsor: University of California, Davis; N=100 ➔ 10; Trial completion date: Oct 2020 ➔ Apr 2020; Recruiting ➔ Terminated; Trial primary completion date: Aug 2020 ➔ Apr 2020; Poor Recruitment

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Oncology • Solid Tumor

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: Roswell Park Cancer Institute; Suspended ➔ Recruiting

Clinical • Enrollment open • HEOR • Head and Neck Cancer • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Assertio Therapeutics Announces First-Quarter 2020 Results (GlobeNewswire, Assertio Therapeutics, Inc.) - "Sale of NUCYNTA Franchise: On February 13, 2020, the Company announced the closing of its definitive agreement with Collegium Pharmaceutical, Inc. pursuant to which Collegium has acquired the NUCYNTA franchise of products from the Company....Sale of Gralise: On January 10, 2020, the Company completed the sale of Gralise to Alvogen. Under the terms of the agreement, Alvogen is expected to pay Assertio a total value of $127.5 million, plus inventory; Completed Strategic Asset Sales of NUCYNTA® Franchise and Gralise® Totaling $502.5 Million."

Commercial • Licensing / partnership • Neuralgia • Pain • Peripheral Neuropathic Pain

Depomed reports first quarter 2015 financial results (PRNewswire) - " '...With NUCYNTA, we are now expecting 2015 total product sales of $310-$335 million, which is nearly triple our 2014 product sales and over five times 2013 product sales.'...First quarter 2015 net sales (for Gralise) were $17.3 million, up 59% compared to $10.9 million in first quarter 2014....First quarter 2015 net sales (for Cambia) were $5.4 million, up 16% compared to $4.6 million in first quarter 2014....First quarter 2015 net sales of $3.2 million (for Lazanda), up 369% compared to $680,000 in first quarter 2014....First quarter 2015 net sales (for Zipsor) of $5.8 million, up 9% compared to $5.3 million in first quarter 2014."

Sales • Sales projection • Pain