ROUND ROCK, Texas, November 13, 2024 – Benuvia Operations, LLC (“Benuvia”), an FDA registered, DEA licensed, and cGMP specializing in pharmaceutical cannabinoids, and the U.S. Department of Veterans Affairs Clinical Science Research and Development Service (VA CSRD) are excited to announce that VA will conduct a Drug Clinical Trial with SYNDROS® (dronabinol) oral solution, CII. This will be a proof-of-concept trial of Cannabis Derivatives in Neuropathic Pain (CDNP) utilizing Benuvia’s SYNDROS®, which is being provided along with placebo by Benuvia Operations, LLC. SYNDROS® is a fully-synthetic FDA-approved THC product with current indications, including Chemotherapy Induced Nausea and Vomiting (CINV) and Anorexia Associated Weight Loss and Aids (AAWLA).
A randomized, controlled, double blind trial is proposed to evaluate the efficacy and safety of Epidiolex®, Sativex®, and SYNDROS® in Veterans with chronic neuropathic pain. Veterans with diabetes are more likely than diabetic civilians to develop chronic disabling peripheral neuropathic pain (CDNP). Chronic neuropathic pain impairs Veterans more than civilians. Research on frontline treatments for CDNP shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabinoid derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabinoids for CDNP. Veterans are also likely to present with pain and pain-related polymorbidity significantly different from that of civilians, so a well-structured clinical trial of cannabinoids for Veterans with CDNP is vital. The study will enroll 320 participants over the next 3 years at 5 VA sites in the U.S. in a randomized phase II, 4-arm clinical trial.
Management Commentary
“Our collaboration with the U.S. Department of Veterans Affairs represents a significant milestone in our commitment to advanced pharmaceutical research and development. We support our Veterans and hope to continue R&D with Benuvia’s high-quality, cGMP certified leadership in small molecule pharmaceutical manufacturing and psychedelics. These products will potentially provide new beneficial FDA-approved medicines for both Veterans and patients suffering from unmet medical needs,” said Terry Novak, CEO of Benuvia.
About Benuvia Operations, LLC
Benuvia Operations, LLC is a global Contract Development and Manufacturing Organization (CDMO) that helps pharmaceutical and biotech companies deliver life-changing therapies to patients in need. The company provides end-to-end development and manufacturing services for Active Pharmaceutical Ingredients (APIs) and finished dosage products and has extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can produce Schedule I-V compounds, offering comprehensive solutions for companies throughout the entire drug development lifecycle—from API synthesis and clinical trial supply to commercial production. Learn more at www.benuvia.com.
About SYNDROS® (dronabinol), oral solution, CII
SYNDROS® (dronabinol) is a prescription medicine approved by the FDA to help improve nausea and vomiting caused by anti-cancer medicine (chemotherapy) in adults whose nausea and vomiting have not improved with usual anti-nausea medicines and loss of appetite (anorexia) in adults with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
Complete prescribing information is available at https://syndros.com/full-prescription-information/. For additional information on SYNDROS®, please see www.syndros.com.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SYNDROS® is contraindicated in patients:
- with a history of a hypersensitivity reaction to Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions (6.2)].
- with a history of a hypersensitivity reaction to
- who are receiving, or have recently received, disulfiram- or metronidazole-containing products within 14 days [see Warning and Precautions (5.3)]. SYNDROS® contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol.
SYNDROS® can cause serious side effects, including:
- Worsening mental (psychiatric) Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take SYNDROS®. SYNDROS® taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SYNDROS® may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
- Problems thinking Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
- Changes in your blood pressure. SYNDROS® may increase or decrease your blood pressure, especially when you start taking SYNDROS® or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
- Interactions with disulfiram or metronidazole. SYNDROS® contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SYNDROS®. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking SYNDROS® and within 7 days after your last dose of SYNDROS®. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing.
SYNDROS® is a controlled substance (CII) because it contains dronabinol which can be a target for people who abuse prescription medicines or street drugs. Keep your SYNDROS® in a safe place to protect it from theft. Never give your SYNDROS® to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.
It is not known if SYNDROS® is safe and effective in children.
Do not take SYNDROS® if you:
- had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
- had an allergic reaction to
- are using a medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulfiram or metronidazole in the last 14 days.
You are encouraged to report adverse events related to SYNDROS®, please contact Benuvia Operations, LLC at 1-844-558-8289. You may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.
Forward-Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. These forward-looking statements should be considered together with the risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
Contact
KWM Communications
Kellie Walsh
(914) 315-6072
kw****@kw***************.com
