Silo Pharma and Partner Receive Regulatory Approval to Begin Development of Ketamine Implant for Fibromyalgia
December 28 2023 - 8:25AM
Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a
developmental stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research, today announced
an update on its dosage and time-release ketamine-loaded implant,
designated as SP-26, which is being developed as a potential
at-home pain relief treatment for fibromyalgia and other chronic
pain conditions. In collaboration with Sever Pharma Solutions,
Silo’s contract development and manufacturing partner, SP-26 is
advancing through analytical testing and small batch pre-clinical
proof of concept extrusion trials to determine drug release and
stability.
Following recent positive compliance inspections from the state
and federal Drug Enforcement Administration (DEA) authorities,
Sever Pharma Solutions now has the required approval from such
state and federal DEA authorities to commence working with ketamine
and loading it into the implant. The dosage and time-release
implant formulation will be studied utilizing the subcutaneous
injection method.
Early preclinical research will focus on the drug’s safety
profile with respect to the FDA’s requirements for potential
designation as an at-home therapeutic. Silo intends to pursue the
FDA’s streamlined 505(b)(2) pathway for approval of SP-26.
Eric Weisblum, Chief Executive Officer of Silo Pharma, commented
“Many chronic pain sufferers are seeking a non-opioid treatment
that offers relief. Based on findings to date, we believe SP-26 has
the potential to be the first at-home approved ketamine treatment
for chronic pain including fibromyalgia.”
The expanding fibromyalgia market was valued at
approximately $3.1 billion in 2022 and is projected to
grow at a compound annual growth rate of 4% over the next decade.1
The broader chronic pain market is projected to exceed $140
billion by 2030.2
About Silo Pharma
Silo Pharma Inc. is a development-stage biopharmaceutical
company focused on merging traditional therapeutics with
psychedelic research for people suffering from indications such as
PTSD, Alzheimer’s disease, and other rare neurological disorders.
Silo’s mission is to identify assets to license and fund the
research which we believe will be transformative to the well-being
of patients and the healthcare industry. For more information visit
www.silopharma.com
Forward-Looking Statements
All statements other than statements of historical fact in this
announcement are forward-looking statements that involve known and
unknown risks and uncertainties and are based on current
expectations and projections about future events and financial
trends that the Company believes may affect its financial
condition, results of operations, business strategy, and financial
needs. Investors can identify these forward-looking statements by
words or phrases such as "may," "will," "expect," "anticipate,"
"aim," "estimate," "intend," "plan," "believe," "potential,"
"continue," "is/are likely to" or other similar expressions. The
Company undertakes no obligation to update forward-looking
statements to reflect subsequent occurring events or circumstances,
or changes in its expectations, except as may be required by law.
Although the Company believes that the expectations expressed in
these forward-looking statements are reasonable, it cannot assure
you that such expectations will turn out to be correct, and the
Company cautions investors that actual results may differ
materially from the anticipated results and encourages investors to
review other factors that may affect its future results in the
Company's filings with the SEC.
Contact
800-705-0120 investors@silopharma.com
1 Allied Market Research: Fibromyalgia Treatment Market
Research, 20322 Spherical Insights: Global Chronic Pain Market
Size…, 2023
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