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Safety in Lactation: Drugs affecting bone metabolism

18 September 2020Drugs used exclusively for postmenopausal osteoporosis have not been included. Bisphosphonates have very poor oral bioavailability in fasting adults, which is decreased even further in…
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Refrigerated Storage

Calcitonin Essential Pharmaceuticals Ltd

Essential Pharmaceuticals Ltd
Calcitonin
Calcitonin 50 IU/ml Solution for Injection and Infusion – Ampoules (single dose) Calcitonin 100 IU/ml Solution for Injection and Infusion – Ampoules (single dose) Calcitonin 400 IU/2ml Solution for Injection and Infusion – Vial (multi dose)

Stability tests have shown that the products, when stored at 25°C as a single exposure, remain stable for a period of up to 3 months.

Yes - the product must be used within 3 months (but not exceeding the original expiry date) and discarded thereafter.
Yes

Please note that the use of the product stored outside the recommended temperature range is considered off-licence, therefore it is entirely of responsibility of the prescriber.

29 April 2019
London MI Service

Lactation Safety Information

Salcatonin

Salcatonin
Yes
No published evidence of safety
Due to the drug’s properties, low milk levels anticipated which are likely to be degraded in infant’s GI tract
11 September 2020

New Medicines

TBRIAOsteoporosis postmenopausal

Information

TBRIA
New formulation
R-Pharm
R-Pharm

Development and Regulatory status

Discontinued
Discontinued
Not approved
Nov 19No further development reported. Not listed on company pipeline [19].
Dec 18R-Pharm JSC acquire rights to TBRIA [18].
Dec 17It appears that the FDA have issued a CRL. A further confirmatory, 48 week study comparing TBRIA with nasal spray calcitonin alone is required to achieved regulatory approval [19].
Dec 17No further development reported [17].
Jan 17No further development reported [16].
Oct 15NDA for TBRIATM filed to the US FDA in July 2015 and accepted with a PDUFA date of May 30, 2016 [15].
Aug 14Company plans to file in US early 2015 [14]
Apr 14In July 2012 the European Medicines Agency recommended that calcitonin medicines should only be used for the shortest possible time using the minimum effective dose. This is based on an increased risk of cancer associated with long-term use [13].
Mar 13Plans to file in US in 2013. The company is also preparing to submit marketing applications in Europe [12]
Oct 12Tarsa is preparing to file in the US for the treatment of postmenopausal osteoporosis in 2013 [11].
Dec 11Tarsa confirmed that it is planning to submit a New Drug Application (NDA) to the FDA in the second half of 2012 [8].
Mar 11Tarsa plans to make regulatory submissions in the US in late 2011 and in Europe in 2012 [5]
Jun 09PIII study started Jun 09 [1].

Category

Osteoclast inhibitor, oral salmon calcitonin
2 million women have osteoporosis in England & Wales, with 1 in 3 women aged >50 years affected [9].
Osteoporosis postmenopausal
Oral

Trial or other data

Oct 12Phase II (TAR01-201 ) trial data reported at the American Society for Bone and Mineral Meeting. Oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in 129 postmenopausal women with low bone mass (osteopenia), and its safety profile did not differ substantially from placebo [11].
Oct 12Phase II TAR01-201 trial evaluated the ability of oral recombinant salmon calcitonin to improve BMD at the lumbar spine in 129 postmenopausal women with low bone mass (osteopenia) at increased risk of fracture. The primary endpoint was the change in BMD at the lumbar spine over the course of the year-long study. Oral calcitonin was superior to placebo in increasing BMD at the lumbar spine and its safety profile did not differ substantially from placebo. [10]
Sep 11Positive safety and efficacy data reported from the ORACAL trial show that Ostora achieved all of the efficacy endpoints in the trial and indicate that the safety profile of Ostora did not substantially differ from nasal calcitonin or placebo. The majority of adverse events were mild or moderate, and Ostora was also significantly less immunogenic than nasal calcitonin spray [7].
Mar 11ORACAL study is a Phase 3 multinational, randomized, double-blind, double-dummy placebo-controlled trial of oral recombinant salmon calcitonin compared to commercially available synthetic salmon calcitonin administered by nasal spray (n=565 postmenopausal women). The primary endpoint was % change in lumbar spine BMD. The results of the study demonstrated that oral salmon calcitonin was significantly superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine after one year of treatment. [6]
Oct 10Tarsa´s oral calcitonin preparation is given once daily & has been shown in clinical studies to deliver the desired blood levels of calcitonin & reduce levels of bone resorption biomarkers [4].
Jul 10Patient enrolment in the global PIII ORACAL trial has completed. The independent Data Monitoring Committee (DMC) has completed two separate safety reviews of patient data and recommended that the trial proceed as planned. The company anticipate reporting data from the trial in 2011. The company state that their product could be the first FDA-approved and commercially available oral formulation of calcitonin [3].
Jul 10NCT00959764: A PIII randomised double-blind, placebo-controlled 48-week study started in Jun 09 comparing oral calcitonin vs nasal spray in 520 women with postmenopausal osteoporosis. It is being conducted in US, EU and S. Africa. Expected completion date Sep 10 [1].
Jul 10Unigene, who produce recombinant calcitonin under a patented SecraPep E. coli manufacturing technology, licensed its PIII programme to Tarsa Therapeutics in 2009 [1,2]